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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 February 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
February 29, 1996
Date Received
December 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 (November 20, 1995)
  • K905120 — SAF FIXATIVE (December 17, 1990)
  • K904773 — P AND T MEDIUM (December 4, 1990)

Other clearances for product code JTO

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

FDA data resources