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510(k) K832575

ANTIBIOTIC ASSAY BROTH by Acumedia Manufacturers, Inc. — Product Code JSA

K832575 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "ANTIBIOTIC ASSAY BROTH". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JSA (Culture Media, Antibiotic Assay), a Class I device regulated under 21 CFR 866.2350. Acumedia Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

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.

  • 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 JSA

  • K881538 — ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR (April 18, 1988)
  • K881537 — ANTIBIOTIC MEDIUM #19 (April 18, 1988)
  • K881536 — ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR (April 18, 1988)
  • K881534 — ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR (April 18, 1988)
  • K881535 — ANTIBIOTIC MEDIUM #6 (April 18, 1988)
  • K832577 — SEED AGAR (September 12, 1983)
  • K832576 — BASE AGAR (September 12, 1983)

FDA data resources