Immulite 2000 Automated Immunoassay Analyzer
FDA 510(k) K970227 · Dpc Cirrus
510(k) numberK970227
Submission
- Device name
- Immulite 2000 Automated Immunoassay Analyzer
- Applicant
- Dpc Cirrus
Randolph, NJ, US - Received
- January 17, 1997
- Decision date
- April 8, 1997
- 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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More from Ortho-Clinical Diagnostics, Inc.
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|---|---|---|
| K980855 | Immulite 2000 Carcinoembryonic Antigen (Cea) KitDHX · Traditional | 04/21/1998SE |
Questions and answers
When was Immulite 2000 Automated Immunoassay Analyzer cleared by the FDA?
Immulite 2000 Automated Immunoassay Analyzer (K970227) received a 510(k) decision of Substantially Equivalent on April 8, 1997, 81 days after the submission was received.
What is the product code of K970227?
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.