The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta Liatest Free Ps.
Device ID | K092170 |
510k Number | K092170 |
Device Name: | STA LIATEST FREE PS |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
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 | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-21 |
Decision Date | 2009-12-22 |
Summary: | summary |