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510(k) K943621

RAPID YEAST PLUS SYSTEM by Innovative Diagnostic Systems, Inc. — Product Code JXB

K943621 is an FDA 510(k) premarket notification submitted by Innovative Diagnostic Systems, Inc. for the device "RAPID YEAST PLUS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code JXB (Kit, Identification, Yeast), a Class I device regulated under 21 CFR 866.2660. Innovative Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1995
Date Received
July 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Yeast
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)
  • 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 JXB

  • K080719 — YEAST TRAFFIC LIGHT PNA FISH (September 12, 2008)
  • K062461 — C. ALBICANS PNA FISH (October 25, 2006)
  • K993554 — YEASTEST (February 10, 2000)
  • K935124 — BACTICARD CANDIDA (February 25, 1994)
  • K900112 — MICRORING YT (July 31, 1990)
  • K881925 — VITEK YEAST BIOCHEMICAL CARD (June 16, 1988)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)
  • K830286 — YEAST IDENT (April 5, 1983)
  • K802309 — MS-2 IDENTIFICATION SYSTEM (December 1, 1980)
  • K800803 — NITRATE SWAB-RAPID TEST (July 8, 1980)

FDA data resources