SPQ MALB CONTROL LEVEL II

Single (specified) Analyte Controls (assayed And Unassayed)

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Spq Malb Control Level Ii.

Pre-market Notification Details

Device IDK934521
510k NumberK934521
Device Name:SPQ MALB CONTROL LEVEL II
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactMary Ellen Best
CorrespondentMary Ellen Best
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-17
Decision Date1993-11-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.