The following data is part of a premarket notification filed by Compass Bioscience with the FDA for Hemoglobin Alc Control.
| Device ID | K060570 |
| 510k Number | K060570 |
| Device Name: | HEMOGLOBIN ALC CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | COMPASS BIOSCIENCE 1850 EVERGREEN ST. Duarte, CA 91010 -2906 |
| Contact | Carter Grandjean |
| Correspondent | Carter Grandjean COMPASS BIOSCIENCE 1850 EVERGREEN ST. Duarte, CA 91010 -2906 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-06 |
| Decision Date | 2006-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238010387 | K060570 | 000 |
| 00857969006426 | K060570 | 000 |