The following data is part of a premarket notification filed by Sascie with the FDA for Sas Serum/urine Hcg.
Device ID | K965250 |
510k Number | K965250 |
Device Name: | SAS SERUM/URINE HCG |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | SASCIE 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Contact | Kathryn Kelley |
Correspondent | Kathryn Kelley SASCIE 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-16 |
Decision Date | 1997-02-18 |