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510(k) K900517

RAPID NF SYSTEM by Innovative Diagnostic Systems, Inc. — Product Code JSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
February 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Glucose Nonfermenter
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Innovative Diagnostic Systems, Inc.

  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K943621 — RAPID YEAST PLUS SYSTEM (January 27, 1995)
  • 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 JSW

  • K922768 — RAPID NFT, MODIFICATION (October 14, 1992)
  • K870769 — AUSTIN NONFERMENTER KIT (April 3, 1987)
  • K790992 — PSEUDO-PALETTE TM (June 22, 1979)
  • K772112 — NON-FERMENTER SYSTEM (November 17, 1977)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)