Els 1000
FDA 510(k) K933548 · Bio-Tek Instruments, Inc.
510(k) numberK933548
Submission
- Device name
- Els 1000
- Applicant
- Bio-Tek Instruments, Inc.
Winooski, VT, US - Received
- July 20, 1993
- Decision date
- October 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
|---|---|---|
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| 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 |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | 10/19/1995SE |
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| 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 |
Questions and answers
When was Els 1000 cleared by the FDA?
Els 1000 (K933548) received a 510(k) decision of Substantially Equivalent on October 29, 1993, 101 days after the submission was received.
What is the product code of K933548?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.