Atlas FDA

DAK

28 FDA 510(k) clearances · Product code

55 daysmedian time to decision
275 days90th percentile
28clearances measured

FDA profile

Official device name
Complement C1q, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5240
Medical specialty
Immunology
Flags
Third-party review eligible
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BINDAZYME CLQ CIC EIA KIT (K031563)The Binding Site, Ltd.2003-09-10
IBL C1Q-CIC CIA TEST (K032254)Ibl GmbH2003-08-29
CIC-C1Q EIA (K012576)American Laboratory Products Co., Ltd.2002-01-29
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES (K973203)Sangstat Medical Corp.1998-09-30
IMMUSTRIP HAMA IGG (K972873)Immunomedics, Inc.1998-03-17
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (K951968)Kent Laboratories, Inc.1995-05-30
C1 RID KIT (K914388)The Binding Site, Ltd.1991-10-28
CIRCULATING IMMUNE COMPLEXES CONTROLS (K882829)Cytotech, Inc.1988-08-04
SANASSAY IC TEST (K860996)Scientific Sales Intl., Inc.1987-03-30
IC MICROASSAY (K864312)Diamedix Corp.1987-01-09
CYTOTECH CIC ENZYME IMMUNOASSAY (K862649)Cytotech, Inc.1986-09-04
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (K861499)Biostar Medical Products, Inc.1986-06-20
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT (K853697)Biostar Medical Products, Inc.1985-12-16
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL (K851202)Gilford1985-04-29
CORDIA IC (K844294)Cordis Corp.1985-02-04
GMP CIQ ELISA TEST KIT (K833275)Gamma Medical Products, Inc.1984-06-22
ORTHO* SERUM ELISA TEST SYSTEM (K833636)Ortho Diagnostic Systems, Inc.1984-06-13
SERUM COMPLEMENT ACTIVITY TEST-SCAT (K841541)Collaborative Research, Inc.1984-06-01
GAMMA CLQ (K823009)Gamma Medical Products, Inc.1982-11-05
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST (K821949)Ortho Diagnostic Systems, Inc.1982-08-27
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM (K821806)Ortho Diagnostic Systems, Inc.1982-06-25
ELECTRO-IMMUNO-QUANTITATION (EIQ) (K792472)Icl Scientific1979-12-27
ANTI-HUMAN CIQ SERUM (K781022)Icl Scientific1978-08-14
LAS-R HUMAN COMPLEMENT CLQ TEST (K780729)Hyland Therapeutic Div., Travenol Laboratories1978-05-18
FIAX C4 ASSAY (K772114)Idt, A Division of Whittaker M.A. Bioproducts1977-11-30
HUMAN REFERENCE SERUM C4 COMPLEMENT (K772003)G.D. Searle and Co.1977-11-03
GOAT ANTISERUM COMPLEMENT C3 NEPHEL. (K770964)Kallestad Laboratories, Inc.1977-06-24
LAS-R TM HUMAN COMPLEMENT C4 TEST (K770547)Hyland Therapeutic Div., Travenol Laboratories1977-05-03

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