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510(k) K833218

YEAST BEEF AGAR-ANTIBIOTIC MED.4 by Acumedia Manufacturers, Inc. — Product Code LKA

K833218 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "YEAST BEEF AGAR-ANTIBIOTIC MED.4". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code LKA (Culture Media, Antimicrobial Susceptibility Test), a Class II device regulated under 21 CFR 866.1700. Acumedia Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1983
Date Received
September 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

Other clearances by Acumedia Manufacturers, Inc.

  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)

Other clearances for product code LKA

  • K872687 — IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (August 11, 1987)
  • K872688 — IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD (August 11, 1987)
  • K872686 — IAFP MUELLER HINTON AGAR (August 11, 1987)
  • K833207 — AK AGAR 2 (October 27, 1983)

FDA data resources