Micromate 196 Model A961960

FDA 510(k) K901808 · Packard Instrument Co., Inc.

Substantially Equivalent

510(k) numberK901808

Submission

Device name
Micromate 196 Model A961960
Applicant
Packard Instrument Co., Inc.
Downers Grove, IL, US
Received
April 20, 1990
Decision date
June 20, 1990
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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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
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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
K873542Microplate Auto-Washer (Motorized Stage)JTC · Traditional Genetic Systems Corp.09/23/1987SE

More from Genetic Systems Corp.

510(k)DeviceDecision
K924907Filtermate Universal HarvesterJTC · Traditional 12/01/1992SE
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Questions and answers

When was Micromate 196 Model A961960 cleared by the FDA?

Micromate 196 Model A961960 (K901808) received a 510(k) decision of Substantially Equivalent on June 20, 1990, 61 days after the submission was received.

What is the product code of K901808?

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