IGM
FDA 510(k) clearance K983132 · decided 1998-11-04
Clearance details
- K-number
- K983132
- Device name
- IGM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-09-08
- Decision date
- 1998-11-04
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DFT
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, 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 |
|---|---|---|
| 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 |
| TINA-QUANT(R) IGM (K862762) | Boehringer Mannheim Corp. | 1986-09-08 |
| QUANTIMETRIC PLUS IGM REAGENT KIT (K855010) | Kallestad Laboratories, Inc. | 1986-02-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clinical Chemistry Immunoglobulin M, List Number 1E01-20 recall (Z-0384-06) | Abbott Laboratories Diagnostic Div | 2006-01-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |