Atlas FDA

DFT

33 FDA 510(k) clearances · Product code

32 daysmedian time to decision
105 days90th percentile
33clearances measured

FDA profile

Official device name
Igm, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
IGM (K983132)Abbott Laboratories1998-11-04
QUANTEX IGM (K962201)Instrumentation Laboratory CO1996-09-25
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (K955797)Randox Laboratories, Ltd.1996-04-05
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (K945522)Beckman-Diagnostic Systems Group1994-12-12
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 Laboratories1987-04-29
TINA-QUANT(R) IGM (K862762)Boehringer Mannheim Corp.1986-09-08
QUANTIMETRIC PLUS IGM REAGENT KIT (K855010)Kallestad Laboratories, Inc.1986-02-28
GILFORD IMMUNOGLOBULIN M REAGENT (K853469)Gilford1985-09-16
AMER. HISTO-ID SYS PRIMARY IGM S7920-31 (K842327)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
OPTIMATE IGM TEST (K841814)Miles Laboratories, Inc.1984-06-22
FITC GOAT ANTI-HUMAN IGM H CHAIN (K832265)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN IGM H CHAIN (K832259)Gelco Diagnostics, Inc.1983-10-28
FIAX IGM TEST KIT (K831608)Intl. Diagnostic Technology1983-06-22
TIA-IGM REAGENT & CALIBRATOR SETS (K831103)Worthington Diagnostic Systems1983-04-27
QUIK-SEP IGM ISOLATION SYSTEM (K830606)Isolab, Inc.1983-03-24
ACA IMMUNOGLOBIN M TEST PACK (K812632)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
AIM SYSTEM (FOR IGM) (K811124)Icl Scientific1981-05-08
AIP SYSTEM-METHOD FOR IGM (K803251)Icl Scientific1981-01-26
GOAT ANTI-HUMAN IGM (K802177)Protos Laboratories1980-10-31
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA (K801282)J.T. Baker Chemical Co.1980-06-30
IMMUNOGLOBULIN M REAGENT SYSTEM (K800167)Calbiochem-Behring Corp.1980-02-05
LANCER L-INA ANTI-IGM (K791402)Sherwood Medical Co.1979-10-17
IMMUNOGLOBULIN M NEPHEL. ASSAY (K772254)Kallestad Laboratories, Inc.1977-12-22
GOAT ANTISERUM IGM NEPHELOMHTRIC (K770963)Kallestad Laboratories, Inc.1977-06-24
LAS-R HUMAN HAPTOGLOBIN TEST (K760917)Hyland Therapeutic Div., Travenol Laboratories1976-12-30
RAPI/TEX-LGM KIT (K760673)Hoechst-Roussel Pharmaceuticals, Inc.1976-12-19
SERUM, IGM ANTI-HUMAN ACID (K760147)Oxford Laboratories, Inc.1976-07-20

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Every clearance here is in the API, with alerts when new ones post.