Corning Calcium PH Analyzer 634
FDA 510(k) K844188 · Corning Medical & Scientific
510(k) numberK844188
Submission
- Device name
- Corning Calcium PH Analyzer 634
- Applicant
- Corning Medical & Scientific
Medfield, MA, US - Received
- October 26, 1984
- Decision date
- February 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFP – Electrode, Ion Specific, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 02/14/2020SE |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer SystemJFP · Traditional | Nova Biomedical Corporation | 08/16/2019SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | Medica Corporation | 12/01/2016SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | Avl Scientific Corp. | 12/11/1998SE |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 08/20/1997SE |
| K963694 | Easylyte Calcium/Chloride AnalyzerJFP · Traditional | Medica Corp. | 11/27/1996SE |
| K961458 | Avl 9180 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 06/12/1996SE |
| K960120 | Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional | Nova Biomedical Corp. | 03/11/1996SE |
| K943091 | Easy Lyte Calcium AnalyzerJFP · Traditional | Medica Corp. | 01/17/1995SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K875122 | Disposable Sterile Syringe FiltersKET · Traditional | 01/12/1988SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | 07/07/1987SE |
| K872076 | Corning Disposable Roller BottlesKJB · Traditional | 06/15/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | 10/03/1986SE |
| K854024 | Corning Magic Mab HCG RadioimmunoassayJHI · Traditional | 11/26/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | 09/16/1985SE |
| K851939 | Corning Certain -IseJIX · Traditional | 06/14/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | 06/13/1985SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | 03/25/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | 03/12/1985SE |
Questions and answers
When was Corning Calcium PH Analyzer 634 cleared by the FDA?
Corning Calcium PH Analyzer 634 (K844188) received a 510(k) decision of Substantially Equivalent on February 4, 1985, 101 days after the submission was received.
What is the product code of K844188?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.