Cleared Traditional

K770764 - TISSUE CULTURE MEDIA W/HEPES BUFFER
(FDA 510(k) Clearance)

K770764 · Microbiological Assoc. · Microbiology device

Jul 1977

Decision

85d

Days

Class 1

Risk

K770764 is an FDA 510(k) clearance for the TISSUE CULTURE MEDIA W/HEPES BUFFER. This device is classified as a Media And Components, Synthetic Cell And Tissue Culture (Class I - General Controls, product code KIT).

Submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977, 85 days after receiving the submission on April 27, 1977.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number	K770764 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 27, 1977
Decision Date	July 21, 1977
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—