Mini Mash 2000

FDA 510(k) K854602 · Dynatech Corp.

Substantially Equivalent

510(k) numberK854602

Submission

Device name
Mini Mash 2000
Applicant
Dynatech Corp.
Alexandria, VA, US
Received
November 18, 1985
Decision date
December 6, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LIB – Device, General Purpose, Microbiology, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Specialty
Microbiology

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K920416Supplementary Reagents for Enzygnost/TmbLIB · Traditional Behring Diagnostics, Inc.04/08/1992SE
K912558Gull ElisawareLIB · Traditional Gull Laboratories, Inc.09/16/1991SE
K872273Corning Easy Wash Elisa PlatesLIB · Traditional Corning Medical & Scientific07/07/1987SE
K871559Cell LifterLIB · Traditional Corning Costar Corp.05/15/1987SE
K864249Normal Saline SterileLIB · Traditional Mds Laboratories, Inc.03/31/1987SE
K863789Corning Elisa PlatesLIB · Traditional Corning Medical & Scientific10/03/1986SE
K862112Microscope SlidesLIB · Traditional Abco Dealers, Inc.06/13/1986SE
K854604Auto MashLIB · Traditional Dynatech Corp.12/06/1985SE
K854603Multi Mash 2000LIB · Traditional Dynatech Corp.12/06/1985SE

More from Dynatech Corp.

510(k)DeviceDecision
K904567Dynatech MR4000 Microplate ReaderJJQ · Traditional 01/28/1991SE
K854604Auto MashLIB · Traditional 12/06/1985SE
K854603Multi Mash 2000LIB · Traditional 12/06/1985SE
K832117Immulon Substrate Removawell StripsLIB · Traditional 08/08/1983SE
K823787Handi-WashLIB · Traditional 03/09/1983SE
K823833Micro Stix #011-010-5000 & HOLDER#5100LIB · Traditional 03/08/1983SE
K830200Microelisa Minireader IILBI · Traditional 02/16/1983SE
K823773Provial II #006-010-0201KDT · Traditional 01/21/1983SE
K823557Removawell Plate LidLIB · Traditional 12/28/1982SE
K822962Microfluor B Removawell StripsLIB · Traditional 11/16/1982SE

Questions and answers

When was Mini Mash 2000 cleared by the FDA?

Mini Mash 2000 (K854602) received a 510(k) decision of Substantially Equivalent on December 6, 1985, 18 days after the submission was received.

What is the product code of K854602?

The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.