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510(k) K853081

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

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

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  • 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)