Auto/Stat Kit
FDA 510(k) K780512 · Pierce Chemical Co.
510(k) numberK780512
Submission
- Device name
- Auto/Stat Kit
- Applicant
- Pierce Chemical Co.
Mchenry, IL, US - Received
- March 30, 1978
- Decision date
- May 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K252488 | ABL90 FLEX PLUS SystemCGA · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| 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 |
|---|---|---|
| K895661 | Glycotest II Glyhb Assay KitLCP · Traditional | 12/07/1989SE |
| K831837 | Clinovative II Diagnostic KitLCP · Traditional | 08/01/1983SE |
| K821360 | Glyco-Gel Test KitLCP · Traditional | 06/02/1982SE |
| K820279 | Glyco-Gel Test KitLCP · Traditional | 04/08/1982SE |
| K781897 | Stat Kit, MicroproteinCEK · Traditional | 01/10/1979SE |
| K780827 | Uric Acid Rapid Stat KitKNK · Traditional | 06/13/1978SE |
| K780826 | Bilirubin Rapid Stat KitCIG · Traditional | 05/26/1978SE |
| K780825 | Triglyceride C-37 Rapid Stat KitJGY · Traditional | 05/26/1978SE |
| K780331 | Cholesterol Rapid Slat Kit HDLCHH · Traditional | 04/06/1978SE |
Questions and answers
When was Auto/Stat Kit cleared by the FDA?
Auto/Stat Kit (K780512) received a 510(k) decision of Substantially Equivalent on May 3, 1978, 34 days after the submission was received.
What is the product code of K780512?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.