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510(k) K844473

HAND-HELD SLIDE READER by Portable Medical Laboratories, Inc. — Product Code LIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 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

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  • K844476 — PORTABLE DIAGNOSTIC LABORATORY (March 13, 1985)
  • K844475 — SPECIMEN COLLECTION & TRANSPORT SYSTEM (February 6, 1985)
  • K844442 — RAPID DIAGNOSTIC KIT (February 1, 1985)

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  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)