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510(k) K822144

IDS STAPHYLOCHROME TEST by Innovative Diagnostic Systems, Inc. — Product Code JWX

K822144 is an FDA 510(k) premarket notification submitted by Innovative Diagnostic Systems, Inc. for the device "IDS STAPHYLOCHROME TEST". The FDA issued a decision of Substantially Equivalent on August 24, 1982. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), 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
August 24, 1982
Date Received
July 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Staphylococcus Aureus
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)
  • K820483 — IDA RAPID O2A SYSTEM (March 15, 1982)
  • K812859 — IDS PORPHYRIN REAGENT (October 26, 1981)

Other clearances for product code JWX

  • K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
  • K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (September 8, 1997)
  • K964315 — REMEL STAPH LATEX KIT (February 7, 1997)
  • K945538 — STAPHAUREX PLUS(TM) (June 1, 1995)
  • K926173 — STAPH-A-LEX(TM) SYSTEM (August 10, 1993)
  • K923212 — SLIDEX STAPH-KIT (September 28, 1992)
  • K905617 — VISI-STAPH (March 29, 1991)
  • K902259 — AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (June 18, 1990)
  • K874019 — STAPHSLIDE (October 28, 1987)
  • K854278 — NEG COMBO BREAKPOINT PANEL POS COMBO (March 4, 1986)

FDA data resources