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510(k) K874933

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

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)

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  • 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)