510(k) K781275
- Device
- CHLORIDE/CARBON DIOXIDE REAGENT SET
- Applicant
- NOBEL SCIENTIFIC INDUSTRIES, INC.
- 510(k) number
- K781275
- Product code
- JFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-31
- Date received
- 1978-07-24
- Regulation
- 862.1170
- Classification name
- Coulometric, Chloride
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003591759
- 1717966
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JFS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | Wescor, Inc. | 2013-03-27 |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Awareness Technology, Inc. | 1992-10-14 |
| K873127 | CHLORIDE REAGENT KIT | A-Kem, Inc. | 1987-10-23 |
| K830217 | REAGENTS CORNING CHLORIDE METER FOR | Fisher Scientific Co., LLC | 1983-02-18 |
| K823106 | RERMCO TEST CHLORIDE REAGENT | Fermco Biochemics, Inc. | 1982-11-16 |
| K820411 | LIQUIZYME CHLORIDE REAGENT | American Research Products Co. | 1982-03-08 |
| K811319 | CHLORIDE REAGENT KIT | Chem-Elec, Inc. | 1981-08-13 |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Chem-Elec, Inc. | 1981-07-01 |
| K810550 | SILVER ANODE | Nobel Scientific Industries, Inc. | 1981-04-08 |
| K810615 | CORNING 925 CHLORIDE METER | Corning Medical & Scientific | 1981-03-17 |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | J.T. Baker Chemical Co. | 1980-10-10 |
| K800585 | NSI CHLORIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-02 |
| K800217 | CHLORIDE REAGENT, CUP & CLEANER | Fisher Scientific Co., LLC | 1980-02-26 |
| K791690 | CHOLORDE REAGENT | Hi Chem, Inc. | 1979-09-17 |
| K790045 | REAGENT KIT, CHLORIDE/CARBON DIOXIDE | J.T. Baker Chemical Co. | 1979-02-22 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases