Model 550 Express Clinical Chemistry Analyzer
FDA 510(k) K872302 · Ciba Corning Diagnostics Corp.
510(k) numberK872302
Submission
- Device name
- Model 550 Express Clinical Chemistry Analyzer
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- June 15, 1987
- Decision date
- September 8, 1987
- 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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| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
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| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
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Questions and answers
When was Model 550 Express Clinical Chemistry Analyzer cleared by the FDA?
Model 550 Express Clinical Chemistry Analyzer (K872302) received a 510(k) decision of Substantially Equivalent on September 8, 1987, 85 days after the submission was received.
What is the product code of K872302?
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.