SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)

Single (specified) Analyte Controls (assayed And Unassayed)

QUIDEL CORP.

The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Serum Hcg Control Set (negative, Low Positive And High Positive).

Pre-market Notification Details

Device IDK974108
510k NumberK974108
Device Name:SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant QUIDEL CORP. 10165 MCKELLAR CT. San Diego,  CA  92121
ContactEdward J Mcmullen
CorrespondentEdward J Mcmullen
QUIDEL CORP. 10165 MCKELLAR CT. San Diego,  CA  92121
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-31
Decision Date1997-11-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30014613002819 K974108 000

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