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510(k) K871671

URINOSCOPY FUNNEL by Portable Medical Laboratories, Inc. — Product Code GHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1987
Date Received
April 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemocytometer
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

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  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 1985)
  • 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 GHO

  • K770980 — EMATOLOGY DILUENT RESERVOIR CLOSURE (July 11, 1977)