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510(k) K881542

HEART INFUSION AGAR by Acumedia Manufacturers, Inc. — Product Code JSG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
April 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Acumedia Manufacturers, Inc.

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  • 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 JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881532 — BLOOD AGAR BASE W/LOW PH (April 18, 1988)
  • K881543 — LETHEEN AGAR (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881562 — TRYPTOSE BLOOD AGAR BASE (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881522 — DEXTROSE AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)