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510(k) K862946

OXOID SIGNAL BLOOD CULTURE SYSTEM by Oxoid U.S.A., Inc. — Product Code JSG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1986
Date Received
August 5, 1986
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

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Other clearances for product code JSG

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  • 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)