AMER. HISTO-ID SYS PRIMARY IGA 2720-21

Iga, Antigen, Antiserum, Control

BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.

The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Amer. Histo-id Sys Primary Iga 2720-21.

Pre-market Notification Details

Device IDK842330
510k NumberK842330
Device Name:AMER. HISTO-ID SYS PRIMARY IGA 2720-21
ClassificationIga, Antigen, Antiserum, Control
Applicant BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-13
Decision Date1984-08-02

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