Cleared Traditional

PARA-PAK FORMALIN

K792705 · Meridian Diagnostics, Inc. · Pathology
Jan 1980
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K792705 is an FDA 510(k) clearance for the PARA-PAK FORMALIN, a Formaldehyde (formalin, Formol) (Class I — General Controls, product code IGG), submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1980, 25 days after receiving the submission on December 27, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K792705 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1979
Decision Date January 21, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGG — Formaldehyde (formalin, Formol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010

Similar Devices — IGG Formaldehyde (formalin, Formol)

ZINC FORMALIN CONCENTRATE
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FORMALDEHYDE SOLUTION, 37%
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K811794 · Richard-Allan Medical Ind., Inc. · Jul 1981
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K792707 · Meridian Diagnostics, Inc. · Jan 1980
FORMALIN BUFFER CONCENTRATE
K771201 · Central Labs. Assoc. MD Pathologists · Aug 1977