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510(k) K962966

IDS RAPID CB PLUS SYSTEM by Innovative Diagnostic Systems, Inc. — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1996
Date Received
July 30, 1996
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 Innovative Diagnostic Systems, Inc.

  • K943621 — RAPID YEAST PLUS SYSTEM (January 27, 1995)
  • K900517 — RAPID NF SYSTEM (March 13, 1990)
  • K882960 — IDS RAPID ANA SYSTEM (August 12, 1988)
  • K881501 — MODIFIED IDS RAPID NH SYSTEM (May 18, 1988)
  • K852871 — IDS RAPID SS/U SYSTEM (July 23, 1985)
  • K852110 — IDS RAPID E PLUS SYSTEM (June 4, 1985)
  • K833654 — IDS RAPID STR SYSTEM (February 13, 1984)
  • K822144 — IDS STAPHYLOCHROME TEST (August 24, 1982)
  • K820483 — IDA RAPID O2A SYSTEM (March 15, 1982)
  • K812859 — IDS PORPHYRIN REAGENT (October 26, 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)
  • 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)
  • K954812 — LYFO(TM) DIFFERIENTAL DISK-PYR (December 20, 1995)