HAPTOGLOBIN
FDA 510(k) clearance K873866 · decided 1987-10-20
Clearance details
- K-number
- K873866
- Device name
- HAPTOGLOBIN
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-24
- Decision date
- 1987-10-20
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DAD
- Device class
- 2
- Regulation number
- 866.5460
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Bedford Mk41 Oqg, GB
- 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 |
| TINA-QUANT HAPTOGLOBIN (K972639) | Boehringer Mannheim Corp. | 1998-01-09 |
| 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 |
| 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.