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510(k) K812181

STAPHYLOCOCCAL PROTEIN A INSOLUBLE by Oxoid U.S.A., Inc. — Product Code LHJ

K812181 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "STAPHYLOCOCCAL PROTEIN A INSOLUBLE". The FDA issued a decision of Substantially Equivalent on August 25, 1981. The device falls under product code LHJ (Staphylococcus Aureus Protein A Insoluble), a Class I device regulated under 21 CFR 866.3700. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
August 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staphylococcus Aureus Protein A Insoluble
Device Class
Class I
Regulation Number
866.3700
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)
  • K855233 — DIAGNOSTIC REAGENT SET-RPLA (November 4, 1986)
  • K855236 — DIAGNOSTIC REAGENT TST-RPLA (November 4, 1986)

Other clearances for product code LHJ

  • K940557 — STAPHYTECT-OD (July 28, 1994)
  • K842709 — IMMUSTAPH LATEX AGGLUTINATION KIT (August 3, 1984)

FDA data resources