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510(k) K854735

MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. by Portable Medical Laboratories, Inc. — Product Code IBJ

K854735 is an FDA 510(k) premarket notification submitted by Portable Medical Laboratories, Inc. for the device "MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.". The FDA issued a decision of Substantially Equivalent on December 10, 1985. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600. Portable Medical Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1985
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Microscope
Device Class
Class I
Regulation Number
864.3600
Review Panel
PA
Submission Type

Other clearances by Portable Medical Laboratories, Inc.

  • K882101 — HEMOGLOBIN SCREENING DEVICE (July 1, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K871671 — URINOSCOPY FUNNEL (May 20, 1987)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K844476 — PORTABLE DIAGNOSTIC LABORATORY (March 13, 1985)
  • K844475 — SPECIMEN COLLECTION & TRANSPORT SYSTEM (February 6, 1985)
  • K844442 — RAPID DIAGNOSTIC KIT (February 1, 1985)
  • K844473 — HAND-HELD SLIDE READER (January 4, 1985)

Other clearances for product code IBJ

  • K874750 — VIDEO ANALYZER 4000 (April 25, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K823040 — PATHOLOGY INSTRUMENTATION & ACCESSORIES (January 14, 1983)
  • K822207 — 2XC MICROSCOPE (August 5, 1982)
  • K821865 — A O MICROSCOPE VIDEO SYSTEM (July 14, 1982)
  • K802818 — PULLEN POCKET SCOPE (April 17, 1981)

FDA data resources