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510(k) K955826

GIBSON ID-M. CAT. by Gibson Laboratories, Inc. — Product Code JTO

K955826 is an FDA 510(k) premarket notification submitted by Gibson Laboratories, Inc. for the device "GIBSON ID-M. CAT.". The FDA issued a decision of Substantially Equivalent on Feb 29, 1996. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Gibson Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 29, 1996
Date Received
Dec 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Gibson Laboratories, Inc.

  • K953247 — GIBSON ID A.E. TEST (Nov 20, 1995)
  • K905120 — SAF FIXATIVE (Dec 17, 1990)
  • K904773 — P AND T MEDIUM (Dec 4, 1990)

Other clearances for product code JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (Sep 1, 2005)
  • K970832 — PYR SWAB (Apr 24, 1997)
  • K970834 — GRAM SWAB (Apr 17, 1997)
  • K970833 — INDOLE SWAB (Apr 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (Feb 6, 1997)
  • K962966 — IDS RAPID CB PLUS SYSTEM (Oct 8, 1996)
  • K961191 — COLISCREEN (Jun 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (Apr 18, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (Feb 6, 1996)
  • K954812 — LYFO(TM) DIFFERIENTAL DISK-PYR (Dec 20, 1995)

FDA data resources