Home / 510(k) Clearances / K853081

510(k) K853081

AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET by Advanced Medical Technology, Inc. — Product Code KJK

K853081 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET". The FDA issued a decision of Substantially Equivalent on August 13, 1985. The device falls under product code KJK (Auramine O), a Class I device regulated under 21 CFR 864.1850. Advanced Medical Technology, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1985
Date Received
July 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Auramine O
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)
  • K852997 — RAPI - STAPH (August 19, 1985)
  • K853187 — ACRIDINE ORANGE FLUORESCENT STAIN (August 13, 1985)

Other clearances for product code KJK

  • K812274 — AURAMINE O MYCROBACTERIAL STAIN SET (September 1, 1981)

FDA data resources