CHOLESTEROL ENZYMATIC ENDPOINT

Enzymatic Esterase--oxidase, Cholesterol

RANDOX LABORATORIES, LTD.

The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Cholesterol Enzymatic Endpoint.

Pre-market Notification Details

Device IDK923504
510k NumberK923504
Device Name:CHOLESTEROL ENZYMATIC ENDPOINT
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland,  IR
ContactJohn Lamont
CorrespondentJohn Lamont
RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland,  IR
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-15
Decision Date1994-01-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055273201284 K923504 000
00630414561073 K923504 000
00630414526744 K923504 000

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