K822988 is an FDA 510(k) clearance for the COAGULASE PLASMA-CITRATED & EDTA. This device is classified as a Plasma, Coagulase, Human, Horse And Rabbit (Class I - General Controls, product code JTL).
Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 24 days after receiving the submission on October 12, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2160.
| 510(k) Number | K822988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1982 |
| Decision Date | November 05, 1982 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTL — Plasma, Coagulase, Human, Horse And Rabbit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2160 |