The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Invader Factor V.
| Device ID | K100980 |
| 510k Number | K100980 |
| Device Name: | INVADER FACTOR V |
| Classification | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Randall J Covill |
| Correspondent | Randall J Covill HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Product Code | NPQ |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-08 |
| Decision Date | 2011-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506695 | K100980 | 000 |
| 15420045506558 | K100980 | 000 |