SLT 340 Attc

FDA 510(k) K915690 · Slt Labinstruments, Inc.

Substantially Equivalent

510(k) numberK915690

Submission

Device name
SLT 340 Attc
Applicant
Slt Labinstruments, Inc.
Research Triangle Park, NC, US
Received
December 23, 1991
Decision date
April 22, 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
JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2300
Specialty
Clinical Chemistry

Other 510(k)s with product code JJQ

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K980120Digene DML 2000 Microplate LuminometerJJQ · Traditional Digene Corp.02/06/1998SE
K973938Alpha 4 LS Automated Microtiterplate Processor and ReaderJJQ · Traditional Sfri, Inc.02/04/1998SE
K974762Stat TracksJJQ · Traditional Awareness Technology, Inc.01/28/1998SE
K962113Anthos Phacts Version Microplate ReaderJJQ · Traditional Columbia Bioscience, Inc.11/05/1996SE
K961183Cbi 7520 ReaderJJQ · Traditional Columbia Bioscience, Inc.08/02/1996SE
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
K953572ELX800UVJJQ · Traditional Bio-Tek Instruments, Inc.10/19/1995SE

More from Bio-Tek Instruments, Inc.

510(k)DeviceDecision
K915689SLT SpectraJJQ · Traditional 04/22/1992SE
K902776Spectrophotometer (Microassay Plate Readers)JJQ · Traditional 07/31/1990SE
K881797Easy Washer II Microplate WasherJJQ · Traditional 06/15/1988SE
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 SLT 340 Attc cleared by the FDA?

SLT 340 Attc (K915690) received a 510(k) decision of Substantially Equivalent on April 22, 1992, 121 days after the submission was received.

What is the product code of K915690?

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