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510(k) K874303

STAPHYLASE TEST by Oxoid U.S.A., Inc. — Product Code LHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1987
Date Received
October 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staphylococcus Aureus Somatic Antigens
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

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  • 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)
  • K855234 — DIAGNOSTIC REAGENT VET-RPLA (November 4, 1986)

Other clearances for product code LHT

  • K863025 — SERO-STAT R II STAPHYLOCOCCUS TEST (September 15, 1986)
  • K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (April 14, 1982)
  • K820531 — ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (April 14, 1982)
  • K820347 — ACCU-STAPH (March 4, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K812368 — RAT BLOOD IN ALSEVER'S, CITRATED (September 9, 1981)
  • K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (September 9, 1981)
  • K812375 — BABY CHICK BLOOD IN ALSEVER'S (September 9, 1981)
  • K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812376 — SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)