Hi Chem Glucose Reagent Kit, Product No. 88807
FDA 510(k) K925551 · Hichem Diagnostics
510(k) numberK925551
Submission
- Device name
- Hi Chem Glucose Reagent Kit, Product No. 88807
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- November 3, 1992
- Decision date
- April 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | 09/06/1995SE |
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| K951751 | Hichem Ast Reagent KitCIT · Traditional | 08/02/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | 02/23/1995SE |
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Questions and answers
When was Hi Chem Glucose Reagent Kit, Product No. 88807 cleared by the FDA?
Hi Chem Glucose Reagent Kit, Product No. 88807 (K925551) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 168 days after the submission was received.
What is the product code of K925551?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.