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COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

FDA 510(k) clearance K983892 · decided 1999-04-13

Clearance details

K-number
K983892
Device name
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
Applicant
Roche Diagnostics/Boehringer Mannheim GmbH
Decision
Substantially Equivalent
Date received
1998-11-03
Decision date
1999-04-13
Days to decision
161 days
Clearance type
Traditional
Product code
JPA
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CoaguChek Pro DM meter; catalog # 1894048 and 1893211. recall (Z-0813-03)Roche Diagnostics Corp.2003-05-14