The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hy-tec/manual Autoimmune Kit For Mitochondria.
| Device ID | K962452 |
| 510k Number | K962452 |
| Device Name: | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Mehdi Alem |
| Correspondent | Mehdi Alem HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-18 |
| Decision Date | 1996-11-25 |