Redi-Check Photmeter Q.A.
FDA 510(k) K923598 · Awareness Technology, Inc.
510(k) numberK923598
Submission
- Device name
- Redi-Check Photmeter Q.A.
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- July 20, 1992
- Decision date
- October 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | Wescor, Inc. | 03/27/2013SE |
| 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 |
|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS · Traditional | 02/27/2018SE |
| K013420 | Chemwell, Also Known AS Project 2900JLW · Abbreviated | 07/19/2002SE |
| K010877 | Chemwell, Model 2900CIX · Abbreviated | 05/23/2001SE |
| K974762 | Stat TracksJJQ · Traditional | 01/28/1998SE |
| K943729 | Dye Check Strips 545-630JJY · Traditional | 12/29/1994SE |
| K941394 | Stat Fax 2600JQW · Traditional | 06/03/1994SE |
| K900224 | Stat FAX(TM)-2100JJQ · Traditional | 03/01/1990SE |
| K892656 | Dri-Dye Check Strips (TM)-405JJX · Traditional | 05/22/1989SE |
| K882938 | Stat Fax(Tm)JJQ · Traditional | 09/09/1988SE |
| K873451 | Project 300 Microassay BP-12, Eia MinilabJJQ · Traditional | 11/04/1987SE |
Questions and answers
When was Redi-Check Photmeter Q.A. cleared by the FDA?
Redi-Check Photmeter Q.A. (K923598) received a 510(k) decision of Substantially Equivalent on October 14, 1992, 86 days after the submission was received.
What is the product code of K923598?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.