The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem Icon Qsr Ckmb Immunoenzymetric Assay.
| Device ID | K884085 |
| 510k Number | K884085 |
| Device Name: | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Martinis, Phd |
| Correspondent | Martinis, Phd HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-27 |
| Decision Date | 1988-12-02 |