The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil F11 & Fv Dna Control.
| Device ID | K093737 |
| 510k Number | K093737 |
| Device Name: | HEMOSIL F11 & FV DNA CONTROL |
| Classification | Quality Control Material, Genetics, Dna |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 BEDFORD ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 BEDFORD ROAD Bedford, MA 01730 |
| Product Code | NZB |
| CFR Regulation Number | 866.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2010-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950453086 | K093737 | 000 |