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510(k) K802493

SPUTASOL by Oxoid U.S.A., Inc. — Product Code IBG

K802493 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "SPUTASOL". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code IBG (Trypsin), a Class I device regulated under 21 CFR 864.4400. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trypsin
Device Class
Class I
Regulation Number
864.4400
Review Panel
PA
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 IBG

  • K771955 — TRYPSIN 1% (November 22, 1977)

FDA data resources