The following data is part of a premarket notification filed by Biochem Immunosystems (u.s.), Inc. with the FDA for Biodata Sr1 Fah-hcg Enzyme Immunoassay Kit.
| Device ID | K954065 |
| 510k Number | K954065 |
| Device Name: | BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | Laurence A Potter |
| Correspondent | Laurence A Potter BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1996-07-10 |