POSITIVE & NEGATIVE HCG URINE CONTROLS

Single (specified) Analyte Controls (assayed And Unassayed)

ARMKEL, LLC.

The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Positive & Negative Hcg Urine Controls.

Pre-market Notification Details

Device IDK821742
510k NumberK821742
Device Name:POSITIVE & NEGATIVE HCG URINE CONTROLS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-14
Decision Date1982-07-02

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