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510(k) K832117

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

K832117 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "IMMULON SUBSTRATE REMOVAWELL STRIPS". The FDA issued a decision of Substantially Equivalent on August 8, 1983. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Dynatech Corp. has at least 10 other 510(k) clearances on record.

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.

  • K904567 — DYNATECH MR4000 MICROPLATE READER (January 28, 1991)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)
  • 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)
  • K822962 — MICROFLUOR B REMOVAWELL STRIPS (November 16, 1982)

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