The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta - Staclot Drvv Screen; Sta - Staclot Drvv Confirm.
| Device ID | K061805 |
| 510k Number | K061805 |
| Device Name: | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM |
| Classification | Reagent, Russel Viper Venom |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Laura Worfolk |
| Correspondent | Laura Worfolk DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-27 |
| Decision Date | 2006-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450003397 | K061805 | 000 |
| 13607450003342 | K061805 | 000 |
| 13607450003335 | K061805 | 000 |