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510(k) K832117

IMMULON SUBSTRATE REMOVAWELL STRIPS by Dynatech Corp. — Product Code LIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1983
Date Received
June 30, 1983
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 Dynatech Corp.

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  • K854603 — MULTI MASH 2000 (December 6, 1985)
  • K823787 — HANDI-WASH (March 9, 1983)
  • K823833 — MICRO STIX #011-010-5000 & HOLDER#5100 (March 8, 1983)
  • K830200 — MICROELISA MINIREADER II (February 16, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K823557 — REMOVAWELL PLATE LID (December 28, 1982)
  • K822960 — MICROFLUOR B PLATE & MICRO FLUOR W PLATE (November 16, 1982)

Other clearances for product code LIB

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  • 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)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)