K840553 is an FDA 510(k) clearance for the HEMASTAPH. This device is classified as a Plasma, Coagulase, Human, Horse And Rabbit (Class I - General Controls, product code JTL).
Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984, 65 days after receiving the submission on February 8, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2160.
| 510(k) Number | K840553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1984 |
| Decision Date | April 13, 1984 |
| Days to Decision | 65 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 |