PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

Catalytic Methods, Amylase

RANDOX LABORATORIES, LTD.

The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Pancreatic Amylase, Ethylidene Blocked-pnpg7 Enzyme Colorimetric Test.

Pre-market Notification Details

Device IDK971825
510k NumberK971825
Device Name:PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
ClassificationCatalytic Methods, Amylase
Applicant RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin,  IE Bt29 4qy
ContactPone Armstrong
CorrespondentPone Armstrong
RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin,  IE Bt29 4qy
Product CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-16
Decision Date1997-07-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414595641 K971825 000
00630414510156 K971825 000
05055273200669 K971825 000
05055273200614 K971825 000
05055273200591 K971825 000

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