SPQ CRP CONTROL LEVEL II

System, Test, C-reactive Protein

INCSTAR CORP.

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

Pre-market Notification Details

Device IDK935075
510k NumberK935075
Device Name:SPQ CRP CONTROL LEVEL II
ClassificationSystem, Test, C-reactive Protein
Applicant INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
ContactMary E Best
CorrespondentMary E Best
INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
Product CodeDCN  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-25
Decision Date1994-01-11

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