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510(k) K822663

FEBRILE ANTIGEN KIT by Oxoid U.S.A., Inc. — Product Code GSO

K822663 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "FEBRILE ANTIGEN KIT". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.), a Class II device regulated under 21 CFR 866.3085. 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
Antigens (Febrile), Agglutination, Brucella Spp.
Device Class
Class II
Regulation Number
866.3085
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 GSO

  • K972394 — VISTA ANTIGEN BRUCELLA ABORTUS (August 25, 1997)
  • K972396 — VISTA ANTIGEN BRUCELLA MELITENSIS (August 25, 1997)
  • K952139 — SAS BRUCELLA SUIS ANTIGEN (July 18, 1995)
  • K952147 — SAS BRUCELLA ABORTUS ANTIGEN (July 17, 1995)
  • K952136 — SAS SALMONELLA H B ANTIGEN (July 17, 1995)
  • K952135 — SAS SALMONELLA H D ANTIGEN (July 17, 1995)
  • K952140 — SAS BRUCELLA MELTIENSIS ANTIGEN (July 17, 1995)
  • K952137 — SAS SALMONELLA H A ANTIGEN (July 17, 1995)
  • K952131 — SAS FEBRILE ANTIGEN SET (July 17, 1995)
  • K885112 — BRUCELLA IFA* (August 15, 1989)

FDA data resources