Lytening TM 6/R
FDA 510(k) K904726 · Amdev, Inc.
510(k) numberK904726
Submission
- Device name
- Lytening TM 6/R
- Applicant
- Amdev, Inc.
Danvers, MA, US - Received
- October 17, 1990
- Decision date
- December 18, 1990
- 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 |
|---|---|---|
| K890524 | Apec Glucose AnalyzerCGA · Traditional | 03/15/1989SE |
| K884731 | Lytening 6 Sodium/Potassium/Ionized Calcium AnalyzJFP · Traditional | 02/03/1989SE |
| K880917 | Lytening 5JGS · Traditional | 05/27/1988SE |
| K863521 | Lytening 2JGS · Traditional | 11/05/1986SE |
| K853832 | Lytening 1JGS · Traditional | 10/04/1985SE |
Questions and answers
When was Lytening TM 6/R cleared by the FDA?
Lytening TM 6/R (K904726) received a 510(k) decision of Substantially Equivalent on December 18, 1990, 62 days after the submission was received.
What is the product code of K904726?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.