Hi Chem Aqueous Glucose Control, Low, Med, High
FDA 510(k) K941433 · Hichem Diagnostics
510(k) numberK941433
Submission
- Device name
- Hi Chem Aqueous Glucose Control, Low, Med, High
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- March 24, 1994
- Decision date
- August 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | 09/06/1995SE |
| K951751 | Hichem Ast Reagent KitCIT · Traditional | 08/02/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
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Questions and answers
When was Hi Chem Aqueous Glucose Control, Low, Med, High cleared by the FDA?
Hi Chem Aqueous Glucose Control, Low, Med, High (K941433) received a 510(k) decision of Substantially Equivalent on August 2, 1994, 131 days after the submission was received.
What is the product code of K941433?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.