ACID PHOSPHATASE REAGENT SET

Acid Phosphatase, Thymolphthale Inmonophosphate

STERLING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK860476
510k NumberK860476
Device Name:ACID PHOSPHATASE REAGENT SET
ClassificationAcid Phosphatase, Thymolphthale Inmonophosphate
Applicant STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights,  MI  48077
ContactDavid Callender
CorrespondentDavid Callender
STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights,  MI  48077
Product CodeCKE  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-07
Decision Date1986-03-05

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