GTQ · Class I · 21 CFR 866.3720

FDA Product Code GTQ: Antistreptolysin - Titer/streptolysin O Reagent

Leading manufacturers include Beckman Instruments, Inc., Analytical Products, Inc. and Behring Diagnostics, Inc..

37
Total
37
Cleared
94d
Avg days
1976
Since

FDA 510(k) Cleared Antistreptolysin - Titer/streptolysin O Reagent Devices (Product Code GTQ)

37 devices
1–24 of 37
Cleared Dec 14, 2005
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323
K052645
Ortho-Clinical Diagnostics
Microbiology · 79d
Cleared Oct 20, 1995
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437
Olympus America, Inc.
Microbiology · 91d
Cleared Jun 28, 1993
TURBIQUANT ASL
K915742
Behring Diagnostics, Inc.
Microbiology · 553d
Cleared Jun 15, 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236
Beckman Instruments, Inc.
Microbiology · 186d
Cleared Mar 19, 1992
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
K915053
Beckman Instruments, Inc.
Microbiology · 140d
Cleared Jul 17, 1991
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT
K912150
Beckman Instruments, Inc.
Microbiology · 63d
Cleared Jun 17, 1991
QM300 CALIBRATOR G PACK
K910885
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 CONTROL G PACK
K910887
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jan 28, 1991
RAPITEX(R) ASL NEW
K903854
Behring Diagnostics, Inc.
Microbiology · 160d
Cleared May 15, 1990
ASO-CUBE(TM)
K901371
Difco Laboratories, Inc.
Microbiology · 53d
Cleared Oct 28, 1985
LASER ASO KIT
K854039
Behring Diagnostics, Inc.
Microbiology · 26d
Cleared Aug 20, 1985
ASO SLIDE EIKEN
K853276
Syn-Kit, Inc.
Microbiology · 15d
Cleared Aug 23, 1984
SERIMM SURE ASO-CHEK CONTROL SERUM
K842839
Analytical Products, Inc.
Immunology · 34d
Cleared Apr 08, 1982
ASO SURE
K820785
Analytical Products, Inc.
Microbiology · 16d
Cleared Apr 08, 1982
ASO SURE PLUS
K820786
Analytical Products, Inc.
Microbiology · 16d
Cleared Jul 08, 1980
ASO QUANTUM, ANTISTREPTOLYSIN O TEST
K801177
Sclavo, Inc.
Microbiology · 53d
Cleared Apr 24, 1980
RAPI/TEX ASO STANDARD SERUM
K800642
Calbiochem-Behring Corp.
Microbiology · 31d
Cleared Jun 15, 1979
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST
K790831
Icl Scientific
Microbiology · 46d

About Product Code GTQ - Regulatory Context