Atac 2000
FDA 510(k) K843059 · Turpen Laboratory Systems, Inc.
510(k) numberK843059
Submission
- Device name
- Atac 2000
- Applicant
- Turpen Laboratory Systems, Inc.
Jackson, NJ, US - Received
- August 3, 1984
- Decision date
- October 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870836 | Atac 1500 Chemistry AnalyzerJJE · Traditional | 04/01/1987SE |
| K863332 | Atac 4300 Hematology Cell CounterGKL · Traditional | 09/29/1986SE |
| K851321 | Atac 2000 Chemistry AnalyzerJQP · Traditional | 04/25/1985SE |
| K832115 | Atac 3000JJE · Traditional | 01/10/1984SE |
| K832116 | Atac 4700 Hematology Cell CounterGIF · Traditional | 10/20/1983SE |
Questions and answers
When was Atac 2000 cleared by the FDA?
Atac 2000 (K843059) received a 510(k) decision of Substantially Equivalent on October 11, 1984, 69 days after the submission was received.
What is the product code of K843059?
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.