GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6

Stain, Papanicolau

ACCRA LABORATORIES, INC.

The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Gill Papanicolaou Stain Ea-1 & 2 Og-6.

Pre-market Notification Details

Device IDK843427
510k NumberK843427
Device Name:GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
ClassificationStain, Papanicolau
Applicant ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHZJ  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-04
Decision Date1984-10-02

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