COAGUCHEK SYSTEM
FDA 510(k) clearance K952625 · decided 1995-11-21
Clearance details
- K-number
- K952625
- Device name
- COAGUCHEK SYSTEM
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-08
- Decision date
- 1995-11-21
- Days to decision
- 166 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
| Record | Firm | Date |
|---|---|---|
| Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 043932010 recall (Z-0099-06) | Roche Diagnostics Corp. | 2005-10-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |