SILVER ANODE
FDA 510(k) clearance K810550 · decided 1981-04-08
Clearance details
- K-number
- K810550
- Device name
- SILVER ANODE
- Applicant
- Nobel Scientific Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-02
- Decision date
- 1981-04-08
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JFS
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC (K121823) | Wescor, Inc. | 2013-03-27 |
| REDI-CHECK PHOTMETER Q.A. (K923598) | Awareness Technology, Inc. | 1992-10-14 |
| CHLORIDE REAGENT KIT (K873127) | A-Kem, Inc. | 1987-10-23 |
| REAGENTS CORNING CHLORIDE METER FOR (K830217) | Fisher Scientific Co., LLC | 1983-02-18 |
| RERMCO TEST CHLORIDE REAGENT (K823106) | Fermco Biochemics, Inc. | 1982-11-16 |
| LIQUIZYME CHLORIDE REAGENT (K820411) | American Research Products Co. | 1982-03-08 |
| CHLORIDE REAGENT KIT (K811319) | Chem-Elec, Inc. | 1981-08-13 |
| CHLORIDE/CARBON DIOXIDE RATE REAGENT (K811701) | Chem-Elec, Inc. | 1981-07-01 |
| CORNING 925 CHLORIDE METER (K810615) | Corning Medical & Scientific | 1981-03-17 |
| BAKER DIAG. ULTRARATE CHLORIDE KIT (K802080) | J.T. Baker Chemical Co. | 1980-10-10 |
| NSI CHLORIDE REAGENT KIT (K800585) | Nobel Scientific Industries, Inc. | 1980-04-02 |
| CHLORIDE REAGENT, CUP & CLEANER (K800217) | Fisher Scientific Co., LLC | 1980-02-26 |
Recalls involving this device
No recalls on record reference this clearance.