TEST FOR KETONE IN URINE(ACETOACETIC AC

Nitroprusside, Ketones (urinary, Non-quant.)

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Test For Ketone In Urine(acetoacetic Ac.

Pre-market Notification Details

Device IDK801270
510k NumberK801270
Device Name:TEST FOR KETONE IN URINE(ACETOACETIC AC
ClassificationNitroprusside, Ketones (urinary, Non-quant.)
Applicant MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJIN  
CFR Regulation Number862.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-28
Decision Date1980-07-08

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