D-Chem
FDA 510(k) K882307 · Photec Diagnostics, Inc.
510(k) numberK882307
Submission
- Device name
- D-Chem
- Applicant
- Photec Diagnostics, Inc.
Little Falls, NJ, US - Received
- June 3, 1988
- Decision date
- August 2, 1988
- 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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| K073370 | TC Matrix Clinical Chemistry AnalyzerJJE · Traditional | Teco Diagnostics | 05/08/2008SE |
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K897169 | Quikread(R) Whole Blood Triglyceride Test KitCDT · Traditional | 02/23/1990SE |
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita.KLI · Traditional | 12/12/1989SE |
| K894057 | Quikread Whole Blood Hdl-Cholesterol Test KitLBS · Traditional | 08/31/1989SE |
| K892224 | D-Chem(Tm) T-Uptake Test Kit for T-Uptake DeterminKHQ · Traditional | 06/16/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | 04/26/1989SE |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole BloodCHH · Traditional | 04/26/1989SE |
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | 03/24/1988SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | 01/24/1986SE |
| K853048 | Apo-Screen Test Set for Hdl-Apolipoptein A-1DER · Traditional | 08/28/1985SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | 08/22/1985SE |
Questions and answers
When was D-Chem cleared by the FDA?
D-Chem (K882307) received a 510(k) decision of Substantially Equivalent on August 2, 1988, 60 days after the submission was received.
What is the product code of K882307?
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.