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510(k) K852997

RAPI - STAPH by Advanced Medical Technology, Inc. — Product Code JWX

K852997 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "RAPI - STAPH". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Advanced Medical Technology, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
July 15, 1985
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 Advanced Medical Technology, Inc.

  • K083626 — DISTRACTABLE WAVE CAGE (October 19, 2009)
  • K983900 — VENOMETER (January 29, 1999)
  • K874571 — PATIENTWATCH (TM) (January 29, 1988)
  • K862777 — MODEL A-8000 ULTRASONIC HANDPIECE CORD (August 11, 1986)
  • K854225 — ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS (December 27, 1985)
  • K853187 — ACRIDINE ORANGE FLUORESCENT STAIN (August 13, 1985)
  • K853081 — AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (August 13, 1985)

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