Chloride Reagent, Cup & Cleaner
FDA 510(k) K800217 · Fisher Scientific Co., LLC
510(k) numberK800217
Submission
- Device name
- Chloride Reagent, Cup & Cleaner
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- February 4, 1980
- Decision date
- February 26, 1980
- 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 |
| 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 |
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| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
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Questions and answers
When was Chloride Reagent, Cup & Cleaner cleared by the FDA?
Chloride Reagent, Cup & Cleaner (K800217) received a 510(k) decision of Substantially Equivalent on February 26, 1980, 22 days after the submission was received.
What is the product code of K800217?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.