The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-r Ostase Immunoradiometric Assay.
| Device ID | K961573 |
| 510k Number | K961573 |
| Device Name: | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | HYBRITECH, INC. P.O. BOX 269006 San Diego, CA 92196 |
| Contact | Isaac A Mizrahi |
| Correspondent | Isaac A Mizrahi HYBRITECH, INC. P.O. BOX 269006 San Diego, CA 92196 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-23 |
| Decision Date | 1996-08-19 |
| Summary: | summary |