Home / 510(k) Clearances / K800430

510(k) K800430

OXIDE ANAEROBIC SYSTEM by Oxoid U.S.A., Inc. — Product Code JTM

K800430 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "OXIDE ANAEROBIC SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code JTM (Anaerobic Box Glove), a Class I device regulated under 21 CFR 866.2120. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
February 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anaerobic Box Glove
Device Class
Class I
Regulation Number
866.2120
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)

FDA data resources