QUICK CULT SLIDE TEST FECAL OCCULT BLOOD

Reagent, Occult Blood

LABORATORY DIAGNOSTICS CO., INC.

The following data is part of a premarket notification filed by Laboratory Diagnostics Co., Inc. with the FDA for Quick Cult Slide Test Fecal Occult Blood.

Pre-market Notification Details

Device IDK761232
510k NumberK761232
Device Name:QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
ClassificationReagent, Occult Blood
Applicant LABORATORY DIAGNOSTICS CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-12-10
Decision Date1976-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B224SB211 K761232 000
B224SB201 K761232 000
B224SB191 K761232 000

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