Q-LINE LTC

Multi-analyte Controls, All Kinds (assayed)

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Q-line Ltc.

Pre-market Notification Details

Device IDK813580
510k NumberK813580
Device Name:Q-LINE LTC
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-24
Decision Date1982-01-18

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