ACID PHOSPHATASE TEST

Acid Phosphatase, Thymolphthale Inmonophosphate

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Acid Phosphatase Test.

Pre-market Notification Details

Device IDK873726
510k NumberK873726
Device Name:ACID PHOSPHATASE TEST
ClassificationAcid Phosphatase, Thymolphthale Inmonophosphate
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances K Loh
CorrespondentFrances K Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeCKE  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-15
Decision Date1988-01-27

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