Panels › Microbiology › Product code GTQ · Class 1
Antistreptolysin - Titer/Streptolysin O Reagent
Regulation 866.3720
0510(k)s in 12 months (37 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in GTQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biokit USA, Inc. | 4 | 0 |
| Analytical Products, Inc. | 3 | 0 |
| Beckman Instruments, Inc. | 3 | 0 |
| Behring Diagnostics, Inc. | 3 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 3 | 0 |
| Texas Immunology, Inc. | 2 | 0 |
| Allied Fisher Scientific | 1 | 0 |
| Ampcor, Inc. | 1 | 0 |
| BD Diagnostic Systems / Lee Laboratories | 0 | 1 |
| Beckman Coulter Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2005 | K052645 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; Ortho-Clinical Diagnostics | GTQ |
| Oct 20, 1995 | K953437 | OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | GTQ |
| Jun 28, 1993 | K915742 | TURBIQUANT ASL Behring Diagnostics, Inc. | GTQ |
| Jun 15, 1993 | K926236 | BECKMAN ANTI-STREPTOLYSIN O KIT Beckman Instruments, Inc. | GTQ |
| Dec 7, 1992 | K924247 | ACCUTEX ASO LATEX TEST J.S. Medical Assoc. | GTQ |
| Sep 18, 1992 | K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL Simplicity Diagnostics, Inc. | GTQ |
| Mar 19, 1992 | K915053 | BECKMAN ANTISTREPTOLYSIN O, MODIFICATION Beckman Instruments, Inc. | GTQ |
| Jul 17, 1991 | K912150 | BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT Beckman Instruments, Inc. | GTQ |
| Jun 24, 1991 | K904416 | CROATEST (R) RHEUMATOID DIAGNOSTIC Biotrax, Inc. | GTQ |
| Jun 17, 1991 | K910887 | QM300 CONTROL G PACK Kallestad Diag, A Div. of Erbamont, Inc. | GTQ |
| Jun 17, 1991 | K910886 | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK Kallestad Diag, A Div. of Erbamont, Inc. | GTQ |
| Jun 17, 1991 | K910885 | QM300 CALIBRATOR G PACK Kallestad Diag, A Div. of Erbamont, Inc. | GTQ |
| May 21, 1991 | K910073 | TARGET ASO TEST Texas Immunology, Inc. | GTQ |
| Jan 28, 1991 | K903854 | RAPITEX(R) ASL NEW Behring Diagnostics, Inc. | GTQ |
| Jan 25, 1991 | K904311 | RHEUMAGEN ASO T-CONTROL Biokit USA, Inc., ES | GTQ |
| May 15, 1990 | K901371 | ASO-CUBE(TM) Difco Laboratories, Inc. | GTQ |
| Oct 24, 1989 | K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) Biokit USA, Inc., ES | GTQ |
| Oct 16, 1989 | K894780 | IMMUNO/ASO Immunostics Co., Inc. | GTQ |
| Jan 31, 1989 | K890025 | QUIK-DOT ANTISTREPTOLYSIN-O Ampcor, Inc. | GTQ |
| Apr 12, 1988 | K881209 | ASO SLIDE TEST Ncs Diagnostics, Inc., CA | GTQ |
| Apr 21, 1987 | K862530 | RAPID AS LATEX Dilab, Inc. | GTQ |
| Apr 18, 1986 | K854991 | REUMAGEN ASL Biokit USA, Inc., ES | GTQ |
| Oct 28, 1985 | K854039 | LASER ASO KIT Behring Diagnostics, Inc. | GTQ |
| Oct 16, 1985 | K853857 | V-TREND ASO PLUS LATEX TEST Texas Immunology, Inc. | GTQ |
| Aug 20, 1985 | K853276 | ASO SLIDE EIKEN Syn-Kit, Inc. | GTQ |
| Jul 19, 1985 | K852701 | FISHER DIAGNOSTIC LATEST ASO TEST KIT Allied Fisher Scientific | GTQ |
| Aug 23, 1984 | K842839 | SERIMM SURE ASO-CHEK CONTROL SERUM Analytical Products, Inc. | GTQ |
| Jun 19, 1984 | K842256 | AS LATEX PLUS Biokit USA, Inc. | GTQ |
| Jun 16, 1983 | K831464 | ASO-CHECK Diagnostic Technology, Inc. | GTQ |
| May 16, 1983 | K831363 | TESTCORP ASO Catheter Technology Corp. | GTQ |
| Apr 8, 1982 | K820786 | ASO SURE PLUS Analytical Products, Inc. | GTQ |
| Apr 8, 1982 | K820785 | ASO SURE Analytical Products, Inc. | GTQ |
| Aug 13, 1981 | K812060 | BI-ASO SLIDE TEST Biologics Intl., Inc. | GTQ |
| Jul 8, 1980 | K801177 | ASO QUANTUM, ANTISTREPTOLYSIN O TEST Sclavo, Inc. | GTQ |
| Apr 24, 1980 | K800642 | RAPI/TEX ASO STANDARD SERUM Calbiochem-Behring Corp. | GTQ |
| Jun 15, 1979 | K790831 | ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST Icl Scientific | GTQ |
| Aug 3, 1976 | K760096 | REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O Gamma Biologicals, Inc. | GTQ |
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