CRESOLPHTHALEIN COMPLEXONE, CALCIUM

Cresolphthalein Complexone, Calcium

TECH-CO, INC.

The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Cresolphthalein Complexone, Calcium.

Pre-market Notification Details

Device IDK864741
510k NumberK864741
Device Name:CRESOLPHTHALEIN COMPLEXONE, CALCIUM
ClassificationCresolphthalein Complexone, Calcium
Applicant TECH-CO, INC. 4378 REILLY Troy,  MI  48098
ContactHappy Chen
CorrespondentHappy Chen
TECH-CO, INC. 4378 REILLY Troy,  MI  48098
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-04
Decision Date1987-01-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10673486001365 K864741 000

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