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510(k) K822665

WILKINS-CHALGREN ANAEROBE BROTH by Oxoid U.S.A., Inc. — Product Code JSC

K822665 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "WILKINS-CHALGREN ANAEROBE BROTH". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
September 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
Review Panel
MI
Submission Type

Other clearances by Oxoid U.S.A., Inc.

  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (February 3, 1989)
  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K874303 — STAPHYLASE TEST (November 6, 1987)
  • K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 813 (August 10, 1987)
  • K872135 — MCBRIDE MEDIUM CM 819 (June 15, 1987)
  • K870945 — RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (June 10, 1987)
  • K862946 — OXOID SIGNAL BLOOD CULTURE SYSTEM (November 5, 1986)
  • K855236 — DIAGNOSTIC REAGENT TST-RPLA (November 4, 1986)
  • K855233 — DIAGNOSTIC REAGENT SET-RPLA (November 4, 1986)

Other clearances for product code JSC

  • K850143 — SPORDEX CULTURE MEDIA (March 5, 1985)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K842849 — TRYPTICASE SOY BROTH (August 3, 1984)
  • K841219 — SHOPPED MEAT CARBOHYDRATE (April 4, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K833300 — SABOURAUD BHI AGAR (November 7, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)

FDA data resources