AIM SYSTEM (FOR IGM)
FDA 510(k) clearance K811124 · decided 1981-05-08
Clearance details
- K-number
- K811124
- Device name
- AIM SYSTEM (FOR IGM)
- Applicant
- Icl Scientific
- Decision
- Substantially Equivalent
- Date received
- 1981-04-24
- Decision date
- 1981-05-08
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DFT
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, 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 |
| TINA-QUANT(R) IGM (K862762) | Boehringer Mannheim Corp. | 1986-09-08 |
Recalls involving this device
No recalls on record reference this clearance.