Easy Analyzer & Easy-Test Reagent
FDA 510(k) K853699 · Diagnostic Systems
510(k) numberK853699
Submission
- Device name
- Easy Analyzer & Easy-Test Reagent
- Applicant
- Diagnostic Systems
Gibbstown, NJ, US - Received
- September 4, 1985
- Decision date
- September 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 |
|---|---|---|
| K905146 | Olympus Urine PHJQY · Traditional | 02/04/1991SE |
| K893691 | Emds Creatine Kinase Item Nimber 65411CGS · Traditional | 08/31/1989SE |
| K893692 | Emds Aspartate Aminotransferase Item Number 65405CIT · Traditional | 08/21/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | 07/25/1989SE |
| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | 06/20/1988SE |
| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | 03/15/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | 12/19/1985SE |
| K853533 | Absorbance Test SolutionJIT · Traditional | 09/16/1985SE |
Questions and answers
When was Easy Analyzer & Easy-Test Reagent cleared by the FDA?
Easy Analyzer & Easy-Test Reagent (K853699) received a 510(k) decision of Substantially Equivalent on September 25, 1985, 21 days after the submission was received.
What is the product code of K853699?
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.