Microplate Washing Device

FDA 510(k) K820992 · Skatron, Inc.

Substantially Equivalent

510(k) numberK820992

Submission

Device name
Microplate Washing Device
Applicant
Skatron, Inc.
Mchenry, IL, US
Received
April 8, 1982
Decision date
May 3, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JTC – Device, Microtiter Diluting/Dispensing
Device class
Class I (low risk)
Regulation
21 CFR 866.2500
Specialty
Microbiology

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K924907Filtermate Universal HarvesterJTC · Traditional Packard Instrument Co., Inc.12/01/1992SE
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K894645Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional Dynatech Laboratories, Inc.10/17/1989SE
K892369Multi-Probe Head PlusJTC · Traditional Hamilton Co.06/02/1989SE
K891768Genetic Systems Microplate WasherJTC · Traditional Genetic Systems Corp.05/01/1989SE
K891766Genetic Systems Microplate Strip WasherJTC · Traditional Genetic Systems Corp.05/01/1989SE
K891765Genetic Systems Pipettor/DilutorJTC · Traditional Genetic Systems Corp.05/01/1989SE
K884695Washer 500 Microelisa SystemJTC · Traditional Organon Teknika Corp.12/13/1988SE
K884125Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional Bio-Tek Instruments, Inc.12/02/1988SE
K874598Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional Dynatech Laboratories, Inc.11/20/1987SE

More from Dynatech Laboratories, Inc.

510(k)DeviceDecision
K82196196 Well DispenserJTC · Traditional 07/22/1982SE
K821034Skatron Repeating DispenserJQW · Traditional 05/03/1982SE
K812860Immunoassay PlateJTC · Traditional 10/26/1981SE

Questions and answers

When was Microplate Washing Device cleared by the FDA?

Microplate Washing Device (K820992) received a 510(k) decision of Substantially Equivalent on May 3, 1982, 25 days after the submission was received.

What is the product code of K820992?

The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.