Panels › Immunology › Product code DFT · Class 2
Igm, Antigen, Antiserum, Control
Regulation 866.5550
0510(k)s in 12 months (33 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in DFT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 1998 | K983132 | IGM Abbott Laboratories | DFT |
| Sep 25, 1996 | K962201 | QUANTEX IGM Instrumentation Laboratory CO | DFT |
| Apr 5, 1996 | K955797 | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd., IE | DFT |
| Dec 12, 1994 | K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS Beckman-Diagnostic Systems Group | DFT |
| Apr 12, 1990 | K901453 | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD Isolab, Inc. | DFT |
| Aug 2, 1989 | K894417 | RAICHEM(TM) SPIA(TM) IGM REAGENTS Reagents Applications, Inc. | DFT |
| Oct 27, 1988 | K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M Orion Diagnostica, Inc., FI | DFT |
| Mar 25, 1988 | K880828 | WAKO(TM) IGM-HA DIRECT Wako Chemicals USA, Inc. | DFT |
| Oct 13, 1987 | K873871 | IMMUNOGLOBULINS M Unipath , Ltd., GB | DFT |
| Jul 9, 1987 | K872237 | KALLESTAD QM300 IGM ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFT |
| Apr 29, 1987 | K871498 | TITAN GEL IMMUNOFIX CONTROLS Helena Laboratories | DFT |
| Sep 8, 1986 | K862762 | TINA-QUANT(R) IGM Boehringer Mannheim Corp. | DFT |
| Feb 28, 1986 | K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT Kallestad Laboratories, Inc. | DFT |
| Sep 16, 1985 | K853469 | GILFORD IMMUNOGLOBULIN M REAGENT Gilford | DFT |
| Aug 2, 1984 | K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 Bartels Immunodiagnostic Supplies, Inc. | DFT |
| Jun 22, 1984 | K841814 | OPTIMATE IGM TEST Miles Laboratories, Inc. | DFT |
| Oct 31, 1983 | K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN Gelco Diagnostics, Inc. | DFT |
| Oct 28, 1983 | K832259 | GOAT ANTI-HUMAN IGM H CHAIN Gelco Diagnostics, Inc. | DFT |
| Jun 22, 1983 | K831608 | FIAX IGM TEST KIT Intl. Diagnostic Technology | DFT |
| Apr 27, 1983 | K831103 | TIA-IGM REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems | DFT |
| Mar 24, 1983 | K830606 | QUIK-SEP IGM ISOLATION SYSTEM Isolab, Inc. | DFT |
| Sep 29, 1981 | K812632 | ACA IMMUNOGLOBIN M TEST PACK E.I. Dupont DE Nemours & Co., Inc. | DFT |
| May 8, 1981 | K811124 | AIM SYSTEM (FOR IGM) Icl Scientific | DFT |
| Jan 26, 1981 | K803251 | AIP SYSTEM-METHOD FOR IGM Icl Scientific | DFT |
| Oct 31, 1980 | K802177 | GOAT ANTI-HUMAN IGM Protos Laboratories | DFT |
| Jun 30, 1980 | K801282 | J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA J.T. Baker Chemical Co. | DFT |
| Feb 5, 1980 | K800167 | IMMUNOGLOBULIN M REAGENT SYSTEM Calbiochem-Behring Corp. | DFT |
| Oct 17, 1979 | K791402 | LANCER L-INA ANTI-IGM Sherwood Medical Co. | DFT |
| Dec 22, 1977 | K772254 | IMMUNOGLOBULIN M NEPHEL. ASSAY Kallestad Laboratories, Inc. | DFT |
| Jun 24, 1977 | K770963 | GOAT ANTISERUM IGM NEPHELOMHTRIC Kallestad Laboratories, Inc. | DFT |
| Dec 30, 1976 | K760917 | LAS-R HUMAN HAPTOGLOBIN TEST Hyland Therapeutic Div., Travenol Laboratories | DFT |
| Dec 19, 1976 | K760673 | RAPI/TEX-LGM KIT Hoechst-Roussel Pharmaceuticals, Inc. | DFT |
| Jul 20, 1976 | K760147 | SERUM, IGM ANTI-HUMAN ACID Oxford Laboratories, Inc. | DFT |
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