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510(k) K855236

DIAGNOSTIC REAGENT TST-RPLA by Oxoid U.S.A., Inc. — Product Code GTN

K855236 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "DIAGNOSTIC REAGENT TST-RPLA". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.), 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
November 4, 1986
Date Received
December 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Staphylococcus Spp.
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)
  • K855235 — DIAGNOSTIC REAGENT PET-RPLA (November 4, 1986)

Other clearances for product code GTN

  • K855233 — DIAGNOSTIC REAGENT SET-RPLA (November 4, 1986)
  • K851949 — STAPHAUREX ZL30 (May 22, 1985)
  • K791453 — AGGLUTINOTEST-STAPHYLOLISIN (September 24, 1979)

FDA data resources