Submission Details
| 510(k) Number | K082462 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
Feb 2009
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K082462 is an FDA 510(k) clearance for the GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on February 6, 2009, 163 days after receiving the submission on August 27, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.
Device Classification
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1665 |
Manufacturer
Similar Devices — JGS Electrode, Ion Specific, Sodium
All 160
K230275 · Abbott Point of Care, Inc.
· Oct 2023
K222438 · Siemens Healthcare Diagnostics, Inc.
· Jul 2023
K220977 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
· Jul 2023
K213486 · Abbott Laboratories
· Mar 2022
K200403 · Nova Biomedical Corporation
· Apr 2020
K183688 · Abbott Point of Care, Inc.
· Feb 2020
More from Diamond Diagnostics, Inc.
View all
K200544
· CEM · Oct 2020
K133751
· JIT · Aug 2014
K124009
· JJY · Apr 2013
K121027
· JIT · Dec 2012
K121040
· CEM · Aug 2012