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510(k) K905617

VISI-STAPH by Connecticut Diagnostics, Ltd. — Product Code JWX

K905617 is an FDA 510(k) premarket notification submitted by Connecticut Diagnostics, Ltd. for the device "VISI-STAPH". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Connecticut Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
December 14, 1990
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 Connecticut Diagnostics, Ltd.

  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K822504 — CDL AUTO-LYSING REAGENT (September 17, 1982)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K801897 — GLUCOSE DIAGNOSTIC REAGENT (October 10, 1980)
  • K801898 — URIC ACID DIAGNOSTIC REAGENT (October 10, 1980)
  • K792465 — CONNECTICUT DIAGNOSTICS, LTS. DIRECT (December 18, 1979)
  • K792339 — CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN (December 6, 1979)
  • K792337 — DONNECT. DIAG. CALCIUM DIAG. REAGENT (December 6, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)

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)
  • 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)
  • K855220 — V-TREND KIT STAPH LATEX TEST (March 3, 1986)

FDA data resources