Liquizyme Chloride Reagent
FDA 510(k) K820411 · American Research Products Co.
510(k) numberK820411
Submission
- Device name
- Liquizyme Chloride Reagent
- Applicant
- American Research Products Co.
Mchenry, IL, US - Received
- February 12, 1982
- Decision date
- March 8, 1982
- 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 |
| 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 |
|---|---|---|
| K942984 | Bun ReagentCDQ · Traditional | 03/01/1995SE |
| K901527 | Biuret (Colormetric), Total ProteinCEK · Traditional | 07/19/1990SE |
| K901964 | Phosphorus Reagents Prod Codes 7763/7764/7563/7463CEO · Traditional | 05/31/1990SE |
| K901960 | Iron Reagents Product Codes 7725 and 7726JMO · Traditional | 05/31/1990SE |
| K900827 | Colorimetric Chloride Product #4314125CHI · Traditional | 05/02/1990SE |
| K901702 | Nad Reduction, Alt/Spgt Codes 7722,7723,7422,7522CKA · Traditional | 04/25/1990SE |
| K900667 | Amresco Ldh-L Reagents Products #7710, 7711CFJ · Traditional | 04/19/1990SE |
| K900666 | Amresco Creatinine Reagents Product #7790, 7791CGX · Traditional | 04/19/1990SE |
| K900571 | Amresco Product Number 7728 (Bilirubin DPD)CIG · Traditional | 04/16/1990SE |
| K900977 | Amresco Inorganic Phosphorus Product #4312500CEO · Traditional | 04/11/1990SE |
Questions and answers
When was Liquizyme Chloride Reagent cleared by the FDA?
Liquizyme Chloride Reagent (K820411) received a 510(k) decision of Substantially Equivalent on March 8, 1982, 24 days after the submission was received.
What is the product code of K820411?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.