LIQUISPEX URINE (MICRO)ALBUMIN CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

CLINICAL CONTROLS, INC.

The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Liquispex Urine (micro)albumin Control.

Pre-market Notification Details

Device IDK962432
510k NumberK962432
Device Name:LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach,  CA  93433
ContactJames F Godfrey
CorrespondentJames F Godfrey
CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach,  CA  93433
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-24
Decision Date1996-07-05

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