Easy Washer II Microplate Washer

FDA 510(k) K881797 · Slt Labinstruments, Inc.

Substantially Equivalent

510(k) numberK881797

Submission

Device name
Easy Washer II Microplate Washer
Applicant
Slt Labinstruments, Inc.
Ronkonkoma, NY, US
Received
April 27, 1988
Decision date
June 15, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2300
Specialty
Clinical Chemistry

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K962113Anthos Phacts Version Microplate ReaderJJQ · Traditional Columbia Bioscience, Inc.11/05/1996SE
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K962166Origen AnalyzerJJQ · Traditional Igen, Inc.07/31/1996SE
K955077Anthos 2010 ReaderJJQ · Traditional Anthos Labtec, Inc.12/04/1995SE
K953710ELX808 Automated Microplate ReadersJJQ · Traditional Bio-Tek Instruments, Inc.10/25/1995SE
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More from Bio-Tek Instruments, Inc.

510(k)DeviceDecision
K915690SLT 340 AttcJJQ · Traditional 04/22/1992SE
K915689SLT SpectraJJQ · Traditional 04/22/1992SE
K902776Spectrophotometer (Microassay Plate Readers)JJQ · Traditional 07/31/1990SE
K873678Spectrophotometer (Microassay Plate Readers)JJQ · Traditional 09/29/1987SE
K844894Photometer Various One for MicrotiterplatesJJQ · Traditional 06/25/1985SE
K844893SLT 223 Dispenser for MicrotiterplatesJTC · Traditional 02/25/1985SE
K844892SLT 220 Washer for MicroititerplatesJTZ · Traditional 02/25/1985SE
K844891SLT 225 Washer/Dispenser for Micro TiterplatesJTC · Traditional 02/25/1985SE

Questions and answers

When was Easy Washer II Microplate Washer cleared by the FDA?

Easy Washer II Microplate Washer (K881797) received a 510(k) decision of Substantially Equivalent on June 15, 1988, 49 days after the submission was received.

What is the product code of K881797?

The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.