PANTRAK E.K.

Starch-dye Bound Polymer, Amylase

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Pantrak E.k..

Pre-market Notification Details

Device IDK810669
510k NumberK810669
Device Name:PANTRAK E.K.
ClassificationStarch-dye Bound Polymer, Amylase
Applicant CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCIW  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-12
Decision Date1981-03-31

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