The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-e Immunoenzymetric Assay For Ckmb Ii.
| Device ID | K872063 |
| 510k Number | K872063 |
| Device Name: | TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | S Kabakoff,phd |
| Correspondent | S Kabakoff,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 | 1987-05-28 |
| Decision Date | 1987-06-19 |