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510(k) K830783

VERI-STAPH by Zeus Technologies — Product Code JWX

K830783 is an FDA 510(k) premarket notification submitted by Zeus Technologies for the device "VERI-STAPH". The FDA issued a decision of Substantially Equivalent on April 8, 1983. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Zeus Technologies has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1983
Date Received
March 11, 1983
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 Zeus Technologies

  • K840012 — INDIRECT FLUORESCENT ANTIBODY MYCO (February 27, 1984)
  • K831026 — INDIRECT FLUORESCENT ANTIBODY REAGENTS (June 22, 1983)
  • K822859 — DIRECT FA CONJUGATE FOR LEGIONELLA SPP (February 16, 1983)

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