First Choice(Tm) Test Strip
FDA 510(k) K946166 · Polymer Technology Intl.
510(k) numberK946166
Submission
- Device name
- First Choice(Tm) Test Strip
- Applicant
- Polymer Technology Intl.
Issaquah, WA, US - Received
- December 19, 1994
- Decision date
- November 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
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| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
| K220328 | EasyStat 300CGA · Traditional | Medica Corporation | 07/26/2024SE |
| K223179 | Cholestech LDX SystemCGA · Dual Track | Alere San Diego, Inc. | 09/20/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K953672 | First Choice Urinary Tract Infection Test StripsJMT · Traditional | 07/01/1996SE |
| K953662 | First Choice Ketones Urine Test StripsJIN · Traditional | 06/14/1996SE |
| K953661 | First Choice Glucose Urine Test StripsJIL · Traditional | 06/14/1996SE |
| K953680 | First Choice Glucose & Ketones Urine Test StripsJIN · Traditional | 06/12/1996SE |
| K950628 | First Choice Test StripCGA · Traditional | 11/08/1995SE |
Questions and answers
When was First Choice(Tm) Test Strip cleared by the FDA?
First Choice(Tm) Test Strip (K946166) received a 510(k) decision of Substantially Equivalent on November 8, 1995, 324 days after the submission was received.
What is the product code of K946166?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.