Assist Clinical Chemistry Analyzer
FDA 510(k) K852262 · Cooper Biomedical, Inc.
510(k) numberK852262
Submission
- Device name
- Assist Clinical Chemistry Analyzer
- Applicant
- Cooper Biomedical, Inc.
Malvern, PA, US - Received
- May 24, 1985
- Decision date
- June 25, 1985
- 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 |
|---|---|---|
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | 02/13/1987SE |
| K863868 | Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 AntDFF · Traditional | 02/13/1987SE |
| K863301 | Demand Total ProteinCEK · Traditional | 09/26/1986SE |
| K861926 | Worthington HDL Precipitating Reagent SetLBR · Traditional | 06/27/1986SE |
| K854130 | Demand Ethyl AlcoholDIC · Traditional | 11/05/1985SE |
| K853949 | Demand Acid Phosphatase ReagentCKB · Traditional | 10/16/1985SE |
| K851285 | Radial Immunodiffusion Plates CSF Igg & CSF AlbumiDCF · Traditional | 06/17/1985SE |
| K851284 | Radial Immuno-Diffusion Plates Iga, Igd, Igg & IgmCZP · Traditional | 06/11/1985SE |
| K851286 | Radial Immunodiffusion Plates C3 & C4CZW · Traditional | 06/05/1985SE |
| K851287 | Radial Immunodiffusion Plates TransferrinDDG · Traditional | 05/24/1985SE |
Questions and answers
When was Assist Clinical Chemistry Analyzer cleared by the FDA?
Assist Clinical Chemistry Analyzer (K852262) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 32 days after the submission was received.
What is the product code of K852262?
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.