PRECINORM HB
FDA 510(k) clearance K852136 · decided 1985-07-05
Clearance details
- K-number
- K852136
- Device name
- PRECINORM HB
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-16
- Decision date
- 1985-07-05
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- GGM
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| GLYCOHEMOSURE HBA1C CONTROL (K032791) | Quantimetrix Corp. | 2003-10-30 |
| LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (K003030) | Bio-Rad | 2000-11-29 |
| R&D HGB/GLC WHOLE BLOOD CONTROL (K993321) | R&D Systems, Inc. | 1999-11-12 |
| HEMOCUE HEMOTROL (K964052) | Direct Solutions | 1996-11-06 |
| HEMOCUE HEMOLIN (K963908) | Direct Solutions | 1996-10-16 |
| CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (K921681) | Isolab, Inc. | 1992-11-17 |
| HGB-CONTROL SET/MULTIPLE (K893985) | R&D Systems, Inc. | 1989-08-15 |
Recalls involving this device
No recalls on record reference this clearance.
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 |