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510(k) K822962

MICROFLUOR B REMOVAWELL STRIPS by Dynatech Corp. — Product Code LIB

K822962 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "MICROFLUOR B REMOVAWELL STRIPS". The FDA issued a decision of Substantially Equivalent on November 16, 1982. 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
November 16, 1982
Date Received
October 5, 1982
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)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)
  • K832117 — IMMULON SUBSTRATE REMOVAWELL STRIPS (August 8, 1983)
  • 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)

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