The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Alkaline Phosphatase, Thymolphthalein Monophosphat.
| Device ID | K880177 |
| 510k Number | K880177 |
| Device Name: | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT |
| Classification | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Happy Chen |
| Correspondent | Happy Chen TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | CIO |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001075 | K880177 | 000 |