Reagents Corning Chloride Meter for
FDA 510(k) K830217 · Fisher Scientific Co., LLC
510(k) numberK830217
Submission
- Device name
- Reagents Corning Chloride Meter for
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- January 24, 1983
- Decision date
- February 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | Wescor, Inc. | 03/27/2013SE |
| 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 |
| 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 |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
Questions and answers
When was Reagents Corning Chloride Meter for cleared by the FDA?
Reagents Corning Chloride Meter for (K830217) received a 510(k) decision of Substantially Equivalent on February 18, 1983, 25 days after the submission was received.
What is the product code of K830217?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.