The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hytec Autoimmune Kits (sm).
| Device ID | K954896 |
| 510k Number | K954896 |
| Device Name: | HYTEC AUTOIMMUNE KITS (SM) |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Thoms M Li |
| Correspondent | Thoms M Li HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-19 |
| Decision Date | 1996-03-22 |