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GTQ — Antistreptolysin - Titer/Streptolysin O Reagent Class I

FDA Device Classification

Classification Details

Product Code
GTQ
Device Class
Class I
Regulation Number
866.3720
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052645ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODDecember 14, 2005
K953437olympus americaOLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOctober 20, 1995
K915742behring diagnosticsTURBIQUANT ASLJune 28, 1993
K926236beckman instrumentsBECKMAN ANTI-STREPTOLYSIN O KITJune 15, 1993
K924247j.s. medical assocACCUTEX ASO LATEX TESTDecember 7, 1992
K922723simplicity diagnosticsTECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSeptember 18, 1992
K915053beckman instrumentsBECKMAN ANTISTREPTOLYSIN O, MODIFICATIONMarch 19, 1992
K912150beckman instrumentsBECKMAN ANTI-STREPTOLYSIN O (ASO) KITJuly 17, 1991
K904416biotraxCROATEST (R) RHEUMATOID DIAGNOSTICJune 24, 1991
K910886kallestad diag, a div. of erbamontQM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKJune 17, 1991
K910887kallestad diag, a div. of erbamontQM300 CONTROL G PACKJune 17, 1991
K910885kallestad diag, a div. of erbamontQM300 CALIBRATOR G PACKJune 17, 1991
K910073texas immunologyTARGET ASO TESTMay 21, 1991
K903854behring diagnosticsRAPITEX(R) ASL NEWJanuary 28, 1991
K904311biokit usaRHEUMAGEN ASO T-CONTROLJanuary 25, 1991
K901371difco laboratoriesASO-CUBE(TM)May 15, 1990
K894486biokit usaQUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)October 24, 1989
K894780immunostics coIMMUNO/ASOOctober 16, 1989
K890025ampcorQUIK-DOT ANTISTREPTOLYSIN-OJanuary 31, 1989
K881209ncs diagnosticsASO SLIDE TESTApril 12, 1988