MULTIPLE, VARIOUS SEDIMENTATION RATE DEVICES MANUFACTURED BY STRECK

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Request for Information Form	Contact Information
Company Name	STRECK
Address	7002 SOUTH 109TH ST.
City, State, Zip	OMAHA, NE 68128
Country	US
FDA Owner/Operator Phone	800-843-0912
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GKB
FDA Classification Name	DEVICE, AUTOMATED SEDIMENTATION RATE
FDA Device Classification Code	General Controls
FDA Regulation Number	864.5800
FDA Common Generic Name	SEDIMENTATION RATE INSTRUMENT KIT
FDA Proprietary Device Name	MULTIPLE, VARIOUS SEDIMENTATION RATE DEVICES
FDA Owner / Operator Number	1950302
FDA Owner / Operator Name	STRECK
FDA Establishment Registration Number	1950302
FDA Registered Establishment Name	STRECK
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-09-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BECKMAN COULTER, INC. 11800 SW 147TH AVE. MIAMI, FL 33196 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	AUTOMATED SEDIMENTATION RATE DEVICE
2	DIESSE DIAGNOSTICA SENESE S.P.A VIA DEL POZZO 5 LOC. S. MARTINO MONTERIGGIONI, SI, 53035 IT 39-02-48591204 / 305-827-5761	DEVICE, AUTOMATED SEDIMENTATION RATE	DEVICE, AUTOMATED SEDIMENTATION RATE
3	GUEST SCIENTIFIC A.G. GEWERBESTRASSE 10 CHAM, CH-6330 SZ 44-17-32 867466 / 44-17-32 867466	SEDIMATIC 100	AUTOMATIC ESR SYSTEM
4	LINEAR CHEMICALS S.L. JOAQUIM COSTA 18, 2A PLANTA BARCELONA, 08390 SP 34-93-4694990 / 410-451-0639	SEDIMENTATION DEVICE	SEDIMENTATION DEVICE
5	LP ITALIANA SPA VIA CARLO REALE,15/4 20157 MILANO ITALY, 19643204 IT 02-393-13646 / 02-393-13646	SEDIMAT	SED RATE READER
6	MECHATRONICS INSTRUMENTS B.V. DE CORANTIJN 13 ZWAAG, 1689 AN NL 31-229-291129 / 401-431-6101	STARRSED COMPACT	AUTOMATED SED RATE DEVICE
7	SARSTEDT, INC. ST. JAMES CHURCH RD. NEWTON, NC 28658 US 49-229-330550 / 828-465-4000	SEDIPLUS S100/S200	AUTOMATED ESR TIMER
8	SIRE ANALYTICAL SYSTEMS S.R.L. VIA BIELLA 121/3 UDINE, 33100 IT 39-043-2547454 / 303-234-9412	MULTIPLE	AUTOMATED SEDIMENTATION RATE DEVICE
9	VITAL DIAGNOSTICS INC. 27 WELLINGTON ROAD LINCOLN, RI 02865 US 401-642-8400 / 401-642-8448	EXCYE 10,20,40,EXCYE M,M SCAN	ESR AUTOMATED ANALYZER