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510(k) K874019

STAPHSLIDE by Ncs Diagnostics, Inc. — Product Code JWX

K874019 is an FDA 510(k) premarket notification submitted by Ncs Diagnostics, Inc. for the device "STAPHSLIDE". The FDA issued a decision of Substantially Equivalent on October 28, 1987. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Ncs Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1987
Date Received
October 2, 1987
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 Ncs Diagnostics, Inc.

  • K943498 — KULTSURE STARSWAB (M210), MODIFICATION (November 30, 1994)
  • K943499 — KULTSURE STARSWAB(M240), MODIFICATION (November 30, 1994)
  • K882811 — STREPSLIDE (October 25, 1988)
  • K881209 — ASO SLIDE TEST (April 12, 1988)
  • K871404 — KULTSURE (April 21, 1987)
  • K870231 — KULTSURE (February 4, 1987)
  • K860178 — KULTSURE (CULTURE TRANSPORT) (April 4, 1986)
  • K860655 — KULTSURE (CATALOGUE NO. M200) (March 6, 1986)
  • K860658 — KULTSURE (CATALOGUE NO. M250) (March 4, 1986)
  • K860657 — KULTSURE (CATALOGUE NO. M240) (March 4, 1986)

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)
  • K854278 — NEG COMBO BREAKPOINT PANEL POS COMBO (March 4, 1986)
  • K855220 — V-TREND KIT STAPH LATEX TEST (March 3, 1986)

FDA data resources