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510(k) K874933

MUG-INDOLE DISC by Scott Laboratories, Inc. — Product Code JTO

K874933 is an FDA 510(k) premarket notification submitted by Scott Laboratories, Inc. for the device "MUG-INDOLE DISC". The FDA issued a decision of Substantially Equivalent on January 5, 1988. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Scott Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1988
Date Received
December 4, 1987
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 Scott Laboratories, Inc.

  • K880694 — B. CAT CONFIRM (June 16, 1988)
  • K874662 — MYCO-FLUOR REAGENT A & B (November 25, 1987)
  • K873509 — IDENTICULT-BL (October 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K863025 — SERO-STAT R II STAPHYLOCOCCUS TEST (September 15, 1986)
  • K852869 — SELECTICULT-CHLAMYDIA (September 19, 1985)
  • K852832 — IDENTICULT-NEISSERIA (July 19, 1985)
  • K852666 — IDENTICULT-AE (July 15, 1985)
  • K841680 — SCOTT SELECTICULT-HSV ISOLATION & (October 30, 1984)
  • K811098 — SERO-STAT STAPHYLOCOCCUS TEST (May 5, 1981)

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)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)

FDA data resources