TINA-QUANT HAPTOGLOBIN
FDA 510(k) clearance K972639 · decided 1998-01-09
Clearance details
- K-number
- K972639
- Device name
- TINA-QUANT HAPTOGLOBIN
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-15
- Decision date
- 1998-01-09
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- DAD
- Device class
- 2
- Regulation number
- 866.5460
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| K-ASSAY HAPTOGLOBIN (K993480) | Kamiya Biomedical Co. | 1999-11-24 |
| N-ASSAY TIA MULTI V-NL (K964301) | Crestat Diagnostics, Inc. | 1997-07-14 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (K963286) | Beckman Instruments, Inc. | 1996-10-07 |
| N/T PROTEIN CONTROL SY/L, M AND H (K952593) | Behring Diagnostics, Inc. | 1995-07-17 |
| IL TEST(TM) HAPTOGLOBIN (HPT) (K915829) | Instrumentation Laboratory CO | 1992-07-29 |
| RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (K911898) | Reagents Applications, Inc. | 1991-05-08 |
| SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (K890562) | Atlantic Antibodies | 1989-02-22 |
| HAPTOGLOBIN (K873866) | Unipath , Ltd. | 1987-10-20 |
| QM300 HAPTOGLOBIN ANTIBODY PACK (K872717) | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-21 |
| IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (K864512) | Cooper Biomedical, Inc. | 1987-02-13 |
| SPQ TEST SYSTEM FOR HAPTOGLOBIN (K850584) | Applications Lab | 1985-03-05 |
| DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (K840404) | Tago, Inc. | 1984-03-09 |
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 |