The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Hcg-check.
Device ID | K991193 |
510k Number | K991193 |
Device Name: | SAS HCG-CHECK |
Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Contact | J. Wessling |
Correspondent | J. Wessling SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Product Code | LCX |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-08 |
Decision Date | 1999-05-04 |