ICA1 Ionized Calcium Analyzer
FDA 510(k) K801848 · The London Co.
510(k) numberK801848
Submission
- Device name
- ICA1 Ionized Calcium Analyzer
- Applicant
- The London Co.
Mchenry, IL, US - Received
- August 4, 1980
- Decision date
- October 31, 1980
- 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 |
|---|---|---|
| K802846 | TCM202 TCPO2 & TCM204 TCPO2/PO2 Rec. Sy.KLK · Traditional | 12/17/1980SE |
| K800224 | Radiometer Acid Base LABORATORY-ABL-3CHL · Traditional | 02/22/1980SE |
| K780652 | Hemoglobin Check Solutions, S2100 OSM-2JKS · Traditional | 07/27/1978SE |
| K771444 | Qualicheck TMJJS · Traditional | 08/16/1977SE |
| K771263 | Radiomhter OSM-2 HemoximeterGHS · Traditional | 08/03/1977SE |
| K760229 | Acid Base System, Radiometer AutomatedCHL · Traditional | 08/26/1976SE |
Questions and answers
When was ICA1 Ionized Calcium Analyzer cleared by the FDA?
ICA1 Ionized Calcium Analyzer (K801848) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 88 days after the submission was received.
What is the product code of K801848?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.