The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Hy.tec/manual Ss-b Auto-antibody.
| Device ID | K962578 |
| 510k Number | K962578 |
| Device Name: | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Mehdi Alem, Ph.d. |
| Correspondent | Mehdi Alem, Ph.d. HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1997-03-07 |