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510(k) K972030

STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS by Oxoid , Ltd. — Product Code JWX

K972030 is an FDA 510(k) premarket notification submitted by Oxoid , Ltd. for the device "STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS". The FDA issued a decision of Substantially Equivalent on September 8, 1997. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Oxoid , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1997
Date Received
June 2, 1997
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 Oxoid , Ltd.

  • K070262 — ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (March 14, 2007)
  • K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (March 17, 2006)
  • K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (September 14, 2004)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M (December 10, 2001)
  • K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K010537 — LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 22, 2000)
  • K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 15, 2000)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)

Other clearances for product code JWX

  • K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
  • 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)
  • K855220 — V-TREND KIT STAPH LATEX TEST (March 3, 1986)

FDA data resources