Home / 510(k) Clearances / K833207

510(k) K833207

AK AGAR 2 by Acumedia Manufacturers, Inc. — Product Code LKA

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.

  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881543 — LETHEEN AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)
  • K881537 — ANTIBIOTIC MEDIUM #19 (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)

Other clearances for product code LKA

  • K872686 — IAFP MUELLER HINTON AGAR (August 11, 1987)
  • K872688 — IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD (August 11, 1987)
  • K872687 — IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (August 11, 1987)
  • K833218 — YEAST BEEF AGAR-ANTIBIOTIC MED.4 (October 27, 1983)