Atlas FDA

DAD

18 FDA 510(k) clearances · Product code

38 daysmedian time to decision
212 days90th percentile
18clearances measured

FDA profile

Official device name
Haptoglobin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5460
Medical specialty
Immunology
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
K-ASSAY HAPTOGLOBIN (K993480)Kamiya Biomedical Co.1999-11-24
TINA-QUANT HAPTOGLOBIN (K972639)Boehringer Mannheim Corp.1998-01-09
N-ASSAY TIA MULTI V-NL (K964301)Crestat Diagnostics, Inc.1997-07-14
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (K963286)Beckman Instruments, Inc.1996-10-07
N/T PROTEIN CONTROL SY/L, M AND H (K952593)Behring Diagnostics, Inc.1995-07-17
IL TEST(TM) HAPTOGLOBIN (HPT) (K915829)Instrumentation Laboratory CO1992-07-29
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (K911898)Reagents Applications, Inc.1991-05-08
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (K890562)Atlantic Antibodies1989-02-22
HAPTOGLOBIN (K873866)Unipath , Ltd.1987-10-20
QM300 HAPTOGLOBIN ANTIBODY PACK (K872717)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-21
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (K864512)Cooper Biomedical, Inc.1987-02-13
SPQ TEST SYSTEM FOR HAPTOGLOBIN (K850584)Applications Lab1985-03-05
DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (K840404)Tago, Inc.1984-03-09
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB (K831957)Kent Laboratories, Inc.1983-07-18
IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO (K812494)Dako Corp.1981-09-23
HAPTOGLOBIN NEPHELOMETRIC ASSAY (K801433)J.T. Baker Chemical Co.1980-07-08
HAPTOGLOBIN NEPHELOMETRIC ASSAY (K772245)Kallestad Laboratories, Inc.1977-12-22
SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID (K760144)Oxford Laboratories, Inc.1976-07-20

Track DAD automatically

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