The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Microprotein Reagent Set.
| Device ID | K070757 |
| 510k Number | K070757 |
| Device Name: | MICROPROTEIN REAGENT SET |
| Classification | Lowry (colorimetric), Total Protein |
| Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Product Code | JGP |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727012753 | K070757 | 000 |
| 00811727011923 | K070757 | 000 |
| 00811727011916 | K070757 | 000 |
| 00817274022825 | K070757 | 000 |
| 00817274022818 | K070757 | 000 |
| 00817274021897 | K070757 | 000 |