The following data is part of a premarket notification filed by Maine Molecular Quality Controls, Inc. with the FDA for Introl Cf Panel I Control, Model: G106.
| Device ID | K083171 |
| 510k Number | K083171 |
| Device Name: | INTROL CF PANEL I CONTROL, MODEL: G106 |
| Classification | Quality Control Material, Genetics, Dna |
| Applicant | MAINE MOLECULAR QUALITY CONTROLS, INC. 10 SOUTHGATE ROAD SUITE 170 Scarborough, ME 04074 |
| Contact | Joan Gordon |
| Correspondent | Joan Gordon MAINE MOLECULAR QUALITY CONTROLS, INC. 10 SOUTHGATE ROAD SUITE 170 Scarborough, ME 04074 |
| Product Code | NZB |
| CFR Regulation Number | 866.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-27 |
| Decision Date | 2008-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852720008008 | K083171 | 000 |
| 00852720008015 | K083171 | 000 |