Cleared Traditional

POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421

K882463 · Lakewood Biochemical Co., Inc. · Microbiology
Jun 1988
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K882463 is an FDA 510(k) clearance for the POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421, a Culture Media, Selective And Non-differential (Class I — General Controls, product code JSJ), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on June 22, 1988, 7 days after receiving the submission on June 15, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K882463 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1988
Decision Date June 22, 1988
Days to Decision 7 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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