The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta-cephascreen Kit.
| Device ID | K053111 |
| 510k Number | K053111 |
| Device Name: | STA-CEPHASCREEN KIT |
| Classification | Activated Partial Thromboplastin |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Jim Barrow |
| Correspondent | Jim Barrow DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-04 |
| Decision Date | 2006-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450003106 | K053111 | 000 |
| 13607450003083 | K053111 | 000 |