FDA Product Code
FDA Product Code DFT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5550
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K983132 | IGM | Abbott Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K962201 | QUANTEX IGM | Instrumentation Laboratory CO | 1996-09-25 | Traditional | PDF ↗ |
| K955797 | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 | Traditional | PDF ↗ |
| K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | Beckman-Diagnostic Systems Group | 1994-12-12 | Traditional | PDF ↗ |
| K901453 | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD | Isolab, Inc. | 1990-04-12 | Traditional | PDF ↗ |
| K894417 | RAICHEM(TM) SPIA(TM) IGM REAGENTS | Reagents Applications, Inc. | 1989-08-02 | Traditional | PDF ↗ |
| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | Orion Diagnostica, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K880828 | WAKO(TM) IGM-HA DIRECT | Wako Chemicals USA, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K873871 | IMMUNOGLOBULINS M | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K872237 | KALLESTAD QM300 IGM ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K871498 | TITAN GEL IMMUNOFIX CONTROLS | Helena Laboratories | 1987-04-29 | Traditional | PDF ↗ |
| K862762 | TINA-QUANT(R) IGM | Boehringer Mannheim Corp. | 1986-09-08 | Traditional | PDF ↗ |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K853469 | GILFORD IMMUNOGLOBULIN M REAGENT | Gilford | 1985-09-16 | Traditional | PDF ↗ |
| K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K841814 | OPTIMATE IGM TEST | Miles Laboratories, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832259 | GOAT ANTI-HUMAN IGM H CHAIN | Gelco Diagnostics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K831608 | FIAX IGM TEST KIT | Intl. Diagnostic Technology | 1983-06-22 | Traditional | PDF ↗ |
| K831103 | TIA-IGM REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | Traditional | PDF ↗ |
| K830606 | QUIK-SEP IGM ISOLATION SYSTEM | Isolab, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K812632 | ACA IMMUNOGLOBIN M TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K811124 | AIM SYSTEM (FOR IGM) | Icl Scientific | 1981-05-08 | Traditional | PDF ↗ |
| K803251 | AIP SYSTEM-METHOD FOR IGM | Icl Scientific | 1981-01-26 | Traditional | PDF ↗ |
| K802177 | GOAT ANTI-HUMAN IGM | Protos Laboratories | 1980-10-31 | Traditional | PDF ↗ |
| K801282 | J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA | J.T. Baker Chemical Co. | 1980-06-30 | Traditional | PDF ↗ |
| K800167 | IMMUNOGLOBULIN M REAGENT SYSTEM | Calbiochem-Behring Corp. | 1980-02-05 | Traditional | PDF ↗ |
| K791402 | LANCER L-INA ANTI-IGM | Sherwood Medical Co. | 1979-10-17 | Traditional | PDF ↗ |
| K772254 | IMMUNOGLOBULIN M NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K770963 | GOAT ANTISERUM IGM NEPHELOMHTRIC | Kallestad Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K760917 | LAS-R HUMAN HAPTOGLOBIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1976-12-30 | Traditional | PDF ↗ |
| K760673 | RAPI/TEX-LGM KIT | Hoechst-Roussel Pharmaceuticals, Inc. | 1976-12-19 | Traditional | PDF ↗ |
| K760147 | SERUM, IGM ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code DFT · Class II · Immunology. Data: openFDA.