Ciba Corning/Shimadzu Model 580 Clini. Chem. Analy
FDA 510(k) K870833 · Ciba Corning Diagnostics Corp.
510(k) numberK870833
Submission
- Device name
- Ciba Corning/Shimadzu Model 580 Clini. Chem. Analy
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- March 3, 1987
- Decision date
- April 1, 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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| 510(k) | Device | Decision |
|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
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| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| 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 |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Ciba Corning/Shimadzu Model 580 Clini. Chem. Analy cleared by the FDA?
Ciba Corning/Shimadzu Model 580 Clini. Chem. Analy (K870833) received a 510(k) decision of Substantially Equivalent on April 1, 1987, 29 days after the submission was received.
What is the product code of K870833?
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.