SPQ PAL CONTROL LEVEL II

Prealbumin, Fitc, Antigen, Antiserum, Control

INCSTAR CORP.

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

Pre-market Notification Details

Device IDK934966
510k NumberK934966
Device Name:SPQ PAL CONTROL LEVEL II
ClassificationPrealbumin, Fitc, Antigen, Antiserum, Control
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 CodeDDS  
CFR Regulation Number866.5060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-15
Decision Date1994-01-11

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