Cleared Traditional

GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038

K873412 · Lakewood Biochemical Co., Inc. · Microbiology
Oct 1987
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K873412 is an FDA 510(k) clearance for the GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038, 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 October 6, 1987, 43 days after receiving the submission on August 24, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K873412 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1987
Decision Date October 06, 1987
Days to Decision 43 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

Similar Devices — JSJ Culture Media, Selective And Non-differential

All 306
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421
K882463 · Lakewood Biochemical Co., Inc. · Jun 1988
DERMATOPHYTE TEST MEDIUM
K881524 · Acumedia Manufacturers, Inc. · Apr 1988
CHAPMAN STONE MEDIUM
K881526 · Acumedia Manufacturers, Inc. · Apr 1988
BRILLIANT GREEN AGAR W/SULFADIAZINE
K881530 · Acumedia Manufacturers, Inc. · Apr 1988
LITTMAN AGAR
K881544 · Acumedia Manufacturers, Inc. · Apr 1988
MITIS SALIVARIUS AGAR
K881547 · Acumedia Manufacturers, Inc. · Apr 1988