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 |