The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta-hybrid Hep Calibrator.
| Device ID | K092937 |
| 510k Number | K092937 |
| Device Name: | STA-HYBRID HEP CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Umberto V Parrotta |
| Correspondent | Umberto V Parrotta DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-24 |
| Decision Date | 2010-08-02 |
| Summary: | summary |