The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Quant Hcg Serum.
Device ID | K944785 |
510k Number | K944785 |
Device Name: | SAS QUANT HCG SERUM |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Contact | Harbi Shadfan |
Correspondent | Harbi Shadfan SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-28 |
Decision Date | 1995-01-17 |