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510(k) K844442

RAPID DIAGNOSTIC KIT by Portable Medical Laboratories, Inc. — Product Code LIB

K844442 is an FDA 510(k) premarket notification submitted by Portable Medical Laboratories, Inc. for the device "RAPID DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on February 1, 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
February 1, 1985
Date Received
November 16, 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)
  • K844476 — PORTABLE DIAGNOSTIC LABORATORY (March 13, 1985)
  • K844475 — SPECIMEN COLLECTION & TRANSPORT SYSTEM (February 6, 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