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510(k) K820483

IDA RAPID O2A SYSTEM by Innovative Diagnostic Systems, Inc. — Product Code JSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1982
Date Received
February 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Anaerobic Identification
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)
  • 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)
  • K812859 — IDS PORPHYRIN REAGENT (October 26, 1981)

Other clearances for product code JSP

  • K945489 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945487 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945488 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K944528 — BBLCRYSTAL ANAEROBE ID SYSTEM (March 7, 1995)
  • K910666 — VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (April 3, 1991)
  • K900996 — VITEK ANAEROBE IDENTIFICATION CARD (May 11, 1990)
  • K881380 — B. FRAGTEX (October 6, 1988)
  • K882960 — IDS RAPID ANA SYSTEM (August 12, 1988)
  • K855235 — DIAGNOSTIC REAGENT PET-RPLA (November 4, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)