TINA-QUANT(R) IGM
FDA 510(k) clearance K862762 · decided 1986-09-08
Clearance details
- K-number
- K862762
- Device name
- TINA-QUANT(R) IGM
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-22
- Decision date
- 1986-09-08
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- DFT
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| IGM (K983132) | Abbott Laboratories | 1998-11-04 |
| QUANTEX IGM (K962201) | Instrumentation Laboratory CO | 1996-09-25 |
| IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (K955797) | Randox Laboratories, Ltd. | 1996-04-05 |
| I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (K945522) | Beckman-Diagnostic Systems Group | 1994-12-12 |
| QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD (K901453) | Isolab, Inc. | 1990-04-12 |
| RAICHEM(TM) SPIA(TM) IGM REAGENTS (K894417) | Reagents Applications, Inc. | 1989-08-02 |
| IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (K884147) | Orion Diagnostica, Inc. | 1988-10-27 |
| WAKO(TM) IGM-HA DIRECT (K880828) | Wako Chemicals USA, Inc. | 1988-03-25 |
| IMMUNOGLOBULINS M (K873871) | Unipath , Ltd. | 1987-10-13 |
| KALLESTAD QM300 IGM ANTIBODY PACK (K872237) | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-09 |
| TITAN GEL IMMUNOFIX CONTROLS (K871498) | Helena Laboratories | 1987-04-29 |
| QUANTIMETRIC PLUS IGM REAGENT KIT (K855010) | Kallestad Laboratories, Inc. | 1986-02-28 |
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 |