Hi Chem Diagnostics Cleaning Neutralizer SOL#88193
FDA 510(k) K853003 · Hi Chem, Inc.
510(k) numberK853003
Submission
- Device name
- Hi Chem Diagnostics Cleaning Neutralizer SOL#88193
- Applicant
- Hi Chem, Inc.
Brea, CA, US - Received
- July 16, 1985
- Decision date
- August 6, 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 |
|---|---|---|
| K960084 | Hichem Glucose/Hk Reagent KitCFR · Traditional | 04/04/1996SE |
| K951818 | Hichem Alt Reagent KitCKA · Traditional | 05/15/1995SE |
| K943684 | Hichem Enzyme Verifier KitJJT · Traditional | 10/04/1994SE |
| K941764 | Hichem Calcium Reagent for the Synchron CX3 Prod. No. 88808CJY · Traditional | 05/13/1994SE |
| K902673 | Hi Chem Total Protein/Albumin Serum Range Lin STNDJJY · Traditional | 07/17/1990SE |
| K863617 | Ion 2/4 Flow Cell Cleaner (Product #88656)JGS · Traditional | 10/24/1986SE |
| K862027 | LDP Reagent Cartridge (No. 88216)CFJ · Traditional | 06/13/1986SE |
| K861893 | GGT Reagent Cartridge (Product No. 88204)JXL · Traditional | 06/05/1986SE |
| K861879 | CK Reagent Cartridge (Product No. 88213)CGS · Traditional | 05/29/1986SE |
| K861419 | Hi Chem Diagnostics LDL Reagent CartridgeCFJ · Traditional | 04/28/1986SE |
Questions and answers
When was Hi Chem Diagnostics Cleaning Neutralizer SOL#88193 cleared by the FDA?
Hi Chem Diagnostics Cleaning Neutralizer SOL#88193 (K853003) received a 510(k) decision of Substantially Equivalent on August 6, 1985, 21 days after the submission was received.
What is the product code of K853003?
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.