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510(k) K871671

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

K871671 is an FDA 510(k) premarket notification submitted by Portable Medical Laboratories, Inc. for the device "URINOSCOPY FUNNEL". The FDA issued a decision of Substantially Equivalent on May 20, 1987. The device falls under product code GHO (Hemocytometer), a Class I device regulated under 21 CFR 864.6160. Portable Medical Laboratories, Inc. has at least 8 other 510(k) clearances on record.

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

Other clearances by Portable Medical Laboratories, Inc.

  • K882101 — HEMOGLOBIN SCREENING DEVICE (July 1, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • 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)

FDA data resources