Atlas FDA

COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING

FDA 510(k) clearance K974569 · decided 1998-01-09

Clearance details

K-number
K974569
Device name
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
Applicant
Boehringer Mannheim Corp.
Decision
Substantially Equivalent
Date received
1997-12-08
Decision date
1998-01-09
Days to decision
32 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 brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional us recall (Z-0737-2007)Roche Diagnostics Corp.2007-04-11
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional us recall (Z-0227-2007)Roche Diagnostics Corp.2006-11-30
Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 043932010 recall (Z-0099-06)Roche Diagnostics Corp.2005-10-28
CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (p recall (Z-1293-03)Roche Diagnostics Corp.2003-10-15
CoaguChek PT test strips, sold in 12 pack. recall (Z-0720-03)Roche Diagnostics Corp.2003-04-10

PMA approvals by this applicant

RecordFirmDate
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
ENZYMUN-TEST{R} AFP (P860044/S001)Boehringer Mannheim Corp.1990-08-03
MICUR-MIC SYSTEMS (P820073)Boehringer Mannheim Corp.1983-06-29