The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-mp Ostase Immunoenzymetric Assay.
| Device ID | K972666 |
| 510k Number | K972666 |
| Device Name: | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | HYBRITECH, INC. 9850 DISTRIBUTION AVE. San Diego, CA 92121 |
| Contact | Gregory P Payne |
| Correspondent | Gregory P Payne HYBRITECH, INC. 9850 DISTRIBUTION AVE. San Diego, CA 92121 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1997-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169690059 | K972666 | 000 |