GTQ — Antistreptolysin - Titer/Streptolysin O Reagent Class I
FDA product code GTQ covers "Antistreptolysin - Titer/Streptolysin O Reagent", a Class I medical device regulated under 21 CFR 866.3720. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052645 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PROD | December 14, 2005 |
| K953437 | olympus america | OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT | October 20, 1995 |
| K915742 | behring diagnostics | TURBIQUANT ASL | June 28, 1993 |
| K926236 | beckman instruments | BECKMAN ANTI-STREPTOLYSIN O KIT | June 15, 1993 |
| K924247 | j.s. medical assoc | ACCUTEX ASO LATEX TEST | December 7, 1992 |
| K922723 | simplicity diagnostics | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL | September 18, 1992 |
| K915053 | beckman instruments | BECKMAN ANTISTREPTOLYSIN O, MODIFICATION | March 19, 1992 |
| K912150 | beckman instruments | BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT | July 17, 1991 |
| K904416 | biotrax | CROATEST (R) RHEUMATOID DIAGNOSTIC | June 24, 1991 |
| K910886 | kallestad diag, a div. of erbamont | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK | June 17, 1991 |
| K910885 | kallestad diag, a div. of erbamont | QM300 CALIBRATOR G PACK | June 17, 1991 |
| K910887 | kallestad diag, a div. of erbamont | QM300 CONTROL G PACK | June 17, 1991 |
| K910073 | texas immunology | TARGET ASO TEST | May 21, 1991 |
| K903854 | behring diagnostics | RAPITEX(R) ASL NEW | January 28, 1991 |
| K904311 | biokit usa | RHEUMAGEN ASO T-CONTROL | January 25, 1991 |
| K901371 | difco laboratories | ASO-CUBE(TM) | May 15, 1990 |
| K894486 | biokit usa | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) | October 24, 1989 |
| K894780 | immunostics co | IMMUNO/ASO | October 16, 1989 |
| K890025 | ampcor | QUIK-DOT ANTISTREPTOLYSIN-O | January 31, 1989 |
| K881209 | ncs diagnostics | ASO SLIDE TEST | April 12, 1988 |