ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT

Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

TECH-CO, INC.

The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Alkaline Phosphatase, Thymolphthalein Monophosphat.

Pre-market Notification Details

Device IDK880177
510k NumberK880177
Device Name:ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
ClassificationThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Applicant TECH-CO, INC. 24111 BEVERLY Oak Park,  MI  48237
ContactHappy Chen
CorrespondentHappy Chen
TECH-CO, INC. 24111 BEVERLY Oak Park,  MI  48237
Product CodeCIO  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-15
Decision Date1988-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10673486001075 K880177 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.