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510(k) K832576

BASE AGAR by Acumedia Manufacturers, Inc. — Product Code JSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antibiotic Assay
Device Class
Class I
Regulation Number
866.2350
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 JSA

  • K881534 — ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR (April 18, 1988)
  • K881536 — ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR (April 18, 1988)
  • K881535 — ANTIBIOTIC MEDIUM #6 (April 18, 1988)
  • K881537 — ANTIBIOTIC MEDIUM #19 (April 18, 1988)
  • K881538 — ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR (April 18, 1988)
  • K832575 — ANTIBIOTIC ASSAY BROTH (September 12, 1983)
  • K832577 — SEED AGAR (September 12, 1983)