Uni-Check Reagent Strip
FDA 510(k) K924398 · Diagnostic Solutions, Inc.
510(k) numberK924398
Submission
- Device name
- Uni-Check Reagent Strip
- Applicant
- Diagnostic Solutions, Inc.
Laguna Hills, CA, US - Received
- August 31, 1992
- Decision date
- December 23, 1992
- 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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| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
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More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K934892 | Relief Plus One Reagent Strip ModificationCGA · Traditional | 01/11/1994SE |
| K921825 | Quick-Check II Reagent StripCGA · Traditional | 08/18/1992SE |
| K800689 | Reagent for Determ. Glutamic-Pyruvic-CKA · Traditional | 05/30/1980SE |
| K800681 | Reagents for Determ. CO2 in Human SerumKMS · Traditional | 05/30/1980SE |
| K800692 | Reagent for Determ. Potassium/In HumanCEM · Traditional | 05/28/1980SE |
| K800691 | Reagent for Determ. Lactate/DehydrogenasCFJ · Traditional | 05/28/1980SE |
| K800690 | Reagent for Determ. Inorganic/PhosphorusCEO · Traditional | 05/28/1980SE |
| K800688 | Reagent for Determ. Glutamic-OxaloaceticCIT · Traditional | 05/28/1980SE |
| K800687 | Reagent for Determ. Glucose in H/SerumCGA · Traditional | 05/28/1980SE |
| K800686 | Reagent for Determ. Direct BilirubinCIG · Traditional | 05/28/1980SE |
Questions and answers
When was Uni-Check Reagent Strip cleared by the FDA?
Uni-Check Reagent Strip (K924398) received a 510(k) decision of Substantially Equivalent on December 23, 1992, 114 days after the submission was received.
What is the product code of K924398?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.