Submission Details
| 510(k) Number | K033061 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2003 |
| Decision Date | November 07, 2003 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
Nov 2003
Decision
39d
Days
Class 2
Risk
About This 510(k) Submission
K033061 is an FDA 510(k) clearance for the CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on November 7, 2003, 39 days after receiving the submission on September 29, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
Similar Devices — JIX Calibrator, Multi-analyte Mixture
All 301
K161140 · Ortho-Clinical Diagnostics, Inc.
· May 2016
K153365 · Siemens Healthcare Diagnostics, Inc.
· Dec 2015
K151552 · Elitechgroup
· Jul 2015
K140790 · Siemens Healthcare Diagnostics
· Jun 2015
K141388 · Beckman Coulter Ireland, Inc.
· Jul 2014
K133330 · Roche Diagnostics
· Nov 2013
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