K052645 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323. This device is classified as a Antistreptolysin - Titer/streptolysin O Reagent (Class I - General Controls, product code GTQ).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 14, 2005, 79 days after receiving the submission on September 26, 2005.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K052645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2005 |
| Decision Date | December 14, 2005 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTQ — Antistreptolysin - Titer/streptolysin O Reagent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3720 |