The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta-liatest Free Protein S Test Kit.
| Device ID | K010963 |
| 510k Number | K010963 |
| Device Name: | STA-LIATEST FREE PROTEIN S TEST KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le |
| Correspondent | Andrew Loc B Le DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-30 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450005165 | K010963 | 000 |