Cleared Traditional

K770004 - P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM
(FDA 510(k) Clearance)

Jan 1977
Decision
11d
Days
Class 1
Risk

K770004 is an FDA 510(k) clearance for the P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM. This device is classified as a Culture Media, Selective And Non-differential (Class I - General Controls, product code JSJ).

Submitted by Scott Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1977, 11 days after receiving the submission on January 3, 1977.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K770004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1977
Decision Date January 14, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSJ — Culture Media, Selective And Non-differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2360

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