EBV IGM TEST

Antiserum, Fluorescent, Epstein-barr Virus

GULL LABORATORIES, INC.

The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Ebv Igm Test.

Pre-market Notification Details

Device IDK822734
510k NumberK822734
Device Name:EBV IGM TEST
ClassificationAntiserum, Fluorescent, Epstein-barr Virus
Applicant GULL LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJRY  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-09
Decision Date1982-12-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733102035 K822734 000
00840733101946 K822734 000

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