Atlas FDA

DBL

24 FDA 510(k) clearances · Product code

98 daysmedian time to decision
364 days90th percentile
24clearances measured

FDA profile

Official device name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts (K180202)Immuno Concepts, N.A. , Ltd.2018-10-19
NOVA LITE ENDOMYSIAL (K980312)Inova Diagnostics, Inc.1998-04-02
WIELISA ANTI-GBM TEST SYSTEM (K974169)Wieslab AB1998-02-17
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (K971464)Euro-Diagnostica AB1997-10-29
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (K971658)Jay H. Geller1997-05-23
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (K963525)Shield Diagnostics, Ltd.1996-11-07
RIT LIVER, KIDNEY, STOMACH IFA KIT (K955431)The Binding Site, Ltd.1996-04-23
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (K953495)Scimedx Corp.1996-04-10
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (K944191)Light Diagnostics1995-03-06
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (K944192)Light Diagnostics1995-03-06
ANTI-RETICULIN ANTIBODY (ARA) TEST (K913360)Immco Diagnostics, Inc.1994-09-26
ANTI-ENDOMYSIAL ANTIBODY TEST (K912551)Immco Diagnostics, Inc.1993-06-09
ANTI-GBM ANTIBODIES QUANTITATIVE KIT (K904181)Biochemical Diagnostic, Inc.1991-09-10
MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT (K902237)Medica Corp.1990-07-09
ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) (K891098)Immco Diagnostics, Inc.1989-03-22
ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) (K891099)Immco Diagnostics, Inc.1989-03-22
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) (K883915)Immco Diagnostics, Inc.1988-10-19
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT (K871194)Cronus1987-04-20
ANTINUCLEAR ANTIBODY SCREEN FLOURESC (K821576)Immuno-Products Industries1982-06-10
AFT SYSTEM PROFICIENCY TESTING PROGRAM (K820088)Calbiochem-Behring Corp.1982-01-26
ANTI-SKIN ANTIBODY TEST SYSTEM (K811261)Zeus Scientific, Inc.1981-08-12
ANTI-DS/N-DNA TEST KIT (K801960)Immuno-Diagnostic Products, Inc.1980-10-10
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST (K792610)Kallestad Laboratories, Inc.1980-02-22
MULTIPLE AUTO ANTIBODY TEST (K791996)Meda Stat Diagnostics, Inc.1980-01-16

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