The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Alkaline Phosphatase.
| Device ID | K864905 |
| 510k Number | K864905 |
| Device Name: | ALKALINE PHOSPHATASE |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | TECH-CO, INC. 4378 REILLY Troy, MI 48098 |
| Contact | Happy Chen |
| Correspondent | Happy Chen TECH-CO, INC. 4378 REILLY Troy, MI 48098 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001068 | K864905 | 000 |
| 10673486001051 | K864905 | 000 |