The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Factor Ii (prothrombin) G20210a Kit.
| Device ID | K033612 |
| 510k Number | K033612 |
| Device Name: | FACTOR II (PROTHROMBIN) G20210A KIT |
| Classification | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Robert A Gregg |
| Correspondent | Robert A Gregg ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | NPR |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-17 |
| Decision Date | 2003-12-18 |
| Summary: | summary |