Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric
FDA 510(k) K121823 · Wescor, Inc.
510(k) numberK121823
Submission
- Device name
- Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric
- Applicant
- Wescor, Inc.
Logan, UT, US - Received
- June 21, 2012
- Decision date
- March 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFS – Coulometric, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | Awareness Technology, Inc. | 10/14/1992SE |
| K873127 | Chloride Reagent KitJFS · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K830217 | Reagents Corning Chloride Meter forJFS · Traditional | Fisher Scientific Co., LLC | 02/18/1983SE |
| K823106 | Rermco Test Chloride ReagentJFS · Traditional | Fermco Biochemics, Inc. | 11/16/1982SE |
| K820411 | Liquizyme Chloride ReagentJFS · Traditional | American Research Products Co. | 03/08/1982SE |
| K811319 | Chloride Reagent KitJFS · Traditional | Chem-Elec, Inc. | 08/13/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | Chem-Elec, Inc. | 07/01/1981SE |
| K810550 | Silver AnodeJFS · Traditional | Nobel Scientific Industries, Inc. | 04/08/1981SE |
| K810615 | Corning 925 Chloride MeterJFS · Traditional | Corning Medical & Scientific | 03/17/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | J.T. Baker Chemical Co. | 10/10/1980SE |
More from J.T. Baker Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | 03/20/2001SE |
| K863395 | Wescor Sweat.Chek Sweat Conductivity AnalyzerCGZ · Traditional | 05/24/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | 05/13/1988SE |
| K881512 | Wescor Gram Stain Pack for Model 7300 AerosprayJTS · Traditional | 04/18/1988SE |
| K880544 | Wescor Stain Concentrate for Model 7100 AerosprayGJL · Traditional | 04/01/1988SE |
| K853973 | Wescor Model 3700 Webster Sweat InducerKTB · Traditional | 10/16/1985SE |
| K834214 | Wescor 5500 Vapor Pressure OsmometerJJM · Traditional | 03/30/1984SE |
| K834208 | Colloid Osmometer 4400JJM · Traditional | 03/23/1984SE |
| K840472 | Sys Macroduct Sweat Collection Sys 3600KTB · Traditional | 03/19/1984SE |
| K833295 | Wescor 7100 Aerospray Slide StainerKPA · Traditional | 10/31/1983SE |
Questions and answers
When was Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric cleared by the FDA?
Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric (K121823) received a 510(k) decision of Substantially Equivalent on March 27, 2013, 279 days after the submission was received.
What is the product code of K121823?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.