Filtermate Universal Harvester

FDA 510(k) K924907 · Packard Instrument Co., Inc.

Substantially Equivalent

510(k) numberK924907

Submission

Device name
Filtermate Universal Harvester
Applicant
Packard Instrument Co., Inc.
Downers Grove, IL, US
Received
September 29, 1992
Decision date
December 1, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K892369Multi-Probe Head PlusJTC · Traditional Hamilton Co.06/02/1989SE
K891768Genetic Systems Microplate WasherJTC · Traditional Genetic Systems Corp.05/01/1989SE
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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
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More from Genetic Systems Corp.

510(k)DeviceDecision
K913664Rosys Models 100 and 200JQW · Traditional 08/30/1991SE
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Questions and answers

When was Filtermate Universal Harvester cleared by the FDA?

Filtermate Universal Harvester (K924907) received a 510(k) decision of Substantially Equivalent on December 1, 1992, 63 days after the submission was received.

What is the product code of K924907?

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