ELX808 Automated Microplate Readers
FDA 510(k) K953710 · Bio-Tek Instruments, Inc.
510(k) numberK953710
Submission
- Device name
- ELX808 Automated Microplate Readers
- Applicant
- Bio-Tek Instruments, Inc.
Winooski, VT, US - Received
- August 9, 1995
- Decision date
- October 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | Otsuka Pharmaceutical Co., Ltd. | 12/21/2001SE |
| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | Digene Corp. | 02/06/1998SE |
| K973938 | Alpha 4 LS Automated Microtiterplate Processor and ReaderJJQ · Traditional | Sfri, Inc. | 02/04/1998SE |
| K974762 | Stat TracksJJQ · Traditional | Awareness Technology, Inc. | 01/28/1998SE |
| K962113 | Anthos Phacts Version Microplate ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 11/05/1996SE |
| K961183 | Cbi 7520 ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 08/02/1996SE |
| K962166 | Origen AnalyzerJJQ · Traditional | Igen, Inc. | 07/31/1996SE |
| K955077 | Anthos 2010 ReaderJJQ · Traditional | Anthos Labtec, Inc. | 12/04/1995SE |
| K953572 | ELX800UVJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/19/1995SE |
| K953005 | Bili-MeterJJQ · Traditional | Olympic Medical Corp. | 09/28/1995SE |
More from Olympic Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K973609 | IDA-4 and Ipt-McFRN · Traditional | 12/18/1997ST |
| K971273 | Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFDQA · Traditional | 10/08/1997SE |
| K961862 | Models IDA-2 Plus and IPT-1FRN · Traditional | 02/26/1997ST |
| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | 11/17/1995SE |
| K953572 | ELX800UVJJQ · Traditional | 10/19/1995SE |
| K950104 | ELX800 and EL800 Automated Microplate ReadersJJQ · Traditional | 03/21/1995SE |
| K942923 | Ceres 900C & Ceres UV900CJJQ · Traditional | 02/06/1995SE |
| K944257 | Lionheart 3 Multi-Parameter SimulatorDRT · Traditional | 09/21/1994SE |
| K933519 | Index SPO2 SimulatorDQA · Traditional | 09/01/1994SE |
| K933548 | Els 1000JJE · Traditional | 10/29/1993SE |
Questions and answers
When was ELX808 Automated Microplate Readers cleared by the FDA?
ELX808 Automated Microplate Readers (K953710) received a 510(k) decision of Substantially Equivalent on October 25, 1995, 77 days after the submission was received.
What is the product code of K953710?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.