The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Cyto-cal Count Tubes.
| Device ID | K090810 |
| 510k Number | K090810 |
| Device Name: | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES |
| Classification | Counter, Differential Cell |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-09-18 |
| Summary: | summary |