K970505 is an FDA 510(k) clearance for the DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/. This device is classified as a System, Automated Platelet Aggregation (Class II - Special Controls, product code JOZ).
Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on November 17, 1997, 280 days after receiving the submission on February 10, 1997.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.
| 510(k) Number | K970505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1997 |
| Decision Date | November 17, 1997 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOZ — System, Automated Platelet Aggregation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5700 |