K863025 is an FDA 510(k) clearance for the SERO-STAT R II STAPHYLOCOCCUS TEST. This device is classified as a Staphylococcus Aureus Somatic Antigens (Class I - General Controls, product code LHT).
Submitted by Scott Laboratories, Inc. (Fiskeville, US). The FDA issued a Cleared decision on September 15, 1986, 35 days after receiving the submission on August 11, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3700.
| 510(k) Number | K863025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1986 |
| Decision Date | September 15, 1986 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LHT — Staphylococcus Aureus Somatic Antigens |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3700 |