The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Pfa-100 Platelet Function Analyzer/pfa Collagen/epinephrine Test Cartridge/pfa Collagen/adp Test Cartridge/.
| Device ID | K970505 |
| 510k Number | K970505 |
| Device Name: | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ |
| Classification | System, Automated Platelet Aggregation |
| Applicant | DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Contact | Bryan Schneider |
| Correspondent | Bryan Schneider DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-11-17 |
| Summary: | summary |