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510(k) K844476

PORTABLE DIAGNOSTIC LABORATORY by Portable Medical Laboratories, Inc. — Product Code LIB

K844476 is an FDA 510(k) premarket notification submitted by Portable Medical Laboratories, Inc. for the device "PORTABLE DIAGNOSTIC LABORATORY". The FDA issued a decision of Substantially Equivalent on March 13, 1985. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Portable Medical Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1985
Date Received
November 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
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)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 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 LIB

  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K871559 — CELL LIFTER (May 15, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)

FDA data resources