The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Mda Simplastin Htf.
| Device ID | K974566 |
| 510k Number | K974566 |
| Device Name: | MDA SIMPLASTIN HTF |
| Classification | Test, Time, Prothrombin |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Rebecca A Rivas |
| Correspondent | Rebecca A Rivas ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-05 |
| Decision Date | 1998-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420241 | K974566 | 000 |
| 15391521420234 | K974566 | 000 |