Atlas FDA

GTQ

37 FDA 510(k) clearances · Product code

63 daysmedian time to decision
186 days90th percentile
37clearances measured

FDA profile

Official device name
Antistreptolysin - Titer/Streptolysin O Reagent
Device class
Class I (low risk)
Regulation
21 CFR 866.3720
Medical specialty
Microbiology
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RecordFirmDate
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; (K052645)Ortho-Clinical Diagnostics2005-12-14
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (K953437)Olympus America, Inc.1995-10-20
TURBIQUANT ASL (K915742)Behring Diagnostics, Inc.1993-06-28
BECKMAN ANTI-STREPTOLYSIN O KIT (K926236)Beckman Instruments, Inc.1993-06-15
ACCUTEX ASO LATEX TEST (K924247)J.S. Medical Assoc.1992-12-07
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (K922723)Simplicity Diagnostics, Inc.1992-09-18
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (K915053)Beckman Instruments, Inc.1992-03-19
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (K912150)Beckman Instruments, Inc.1991-07-17
CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416)Biotrax, Inc.1991-06-24
QM300 CALIBRATOR G PACK (K910885)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (K910886)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
QM300 CONTROL G PACK (K910887)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
TARGET ASO TEST (K910073)Texas Immunology, Inc.1991-05-21
RAPITEX(R) ASL NEW (K903854)Behring Diagnostics, Inc.1991-01-28
RHEUMAGEN ASO T-CONTROL (K904311)Biokit USA, Inc.1991-01-25
ASO-CUBE(TM) (K901371)Difco Laboratories, Inc.1990-05-15
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) (K894486)Biokit USA, Inc.1989-10-24
IMMUNO/ASO (K894780)Immunostics Co., Inc.1989-10-16
QUIK-DOT ANTISTREPTOLYSIN-O (K890025)Ampcor, Inc.1989-01-31
ASO SLIDE TEST (K881209)Ncs Diagnostics, Inc.1988-04-12
RAPID AS LATEX (K862530)Dilab, Inc.1987-04-21
REUMAGEN ASL (K854991)Biokit USA, Inc.1986-04-18
LASER ASO KIT (K854039)Behring Diagnostics, Inc.1985-10-28
V-TREND ASO PLUS LATEX TEST (K853857)Texas Immunology, Inc.1985-10-16
ASO SLIDE EIKEN (K853276)Syn-Kit, Inc.1985-08-20
FISHER DIAGNOSTIC LATEST ASO TEST KIT (K852701)Allied Fisher Scientific1985-07-19
SERIMM SURE ASO-CHEK CONTROL SERUM (K842839)Analytical Products, Inc.1984-08-23
AS LATEX PLUS (K842256)Biokit USA, Inc.1984-06-19
ASO-CHECK (K831464)Diagnostic Technology, Inc.1983-06-16
TESTCORP ASO (K831363)Catheter Technology Corp.1983-05-16
ASO SURE (K820785)Analytical Products, Inc.1982-04-08
ASO SURE PLUS (K820786)Analytical Products, Inc.1982-04-08
BI-ASO SLIDE TEST (K812060)Biologics Intl., Inc.1981-08-13
ASO QUANTUM, ANTISTREPTOLYSIN O TEST (K801177)Sclavo, Inc.1980-07-08
RAPI/TEX ASO STANDARD SERUM (K800642)Calbiochem-Behring Corp.1980-04-24
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST (K790831)Icl Scientific1979-06-15
REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O (K760096)Gamma Biologicals, Inc.1976-08-03

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