510(k) K933696
- Device
- SIGMA ELECTROLYTE REFERENCE REAGENT
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K933696
- Product code
- JFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-03
- Date received
- 1993-07-29
- Regulation
- 862.1160
- Classification name
- Ph Rate Measurement, Carbon-dioxide
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM R GILBERT
- Address
- 545 S. Ewing Ave. St. Louis MO US 63103 63103
FDA Registration Numbers#
- 3004959793
- 3005643513
- 3000126629
- 3010825766
- 2030861
- 9610816
- 2517506
- 2245578
- 2050010
- 2050012
- 3011989923
- 3006198300
- 1219029
- 9680746
- 3012817228
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JFL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 |
| K040975 | GENCHEM CO2 ACID REAGENT | Genchem, Inc. | 2004-12-27 |
| K014034 | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | Beckman Coulter, Inc. | 2001-12-18 |
| K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT | Sigma Diagnostics, Inc. | 1996-10-24 |
| K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | Sigma Diagnostics, Inc. | 1996-10-11 |
| K963540 | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | Sigma Diagnostics, Inc. | 1996-09-27 |
| K963005 | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | Nova Biomedical Corp. | 1996-08-23 |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Sigma Chemical Co. | 1993-12-17 |
| K933692 | SIGMA CO2 ACID REAGENT | Sigma Chemical Co. | 1993-12-09 |
| K933695 | SIGMA ELECTROLYTE BUFFER | Sigma Chemical Co. | 1993-10-22 |
| K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | Hichem Diagnostics | 1993-02-12 |
| K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | Hichem Diagnostics | 1993-02-12 |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | Niic U.S.A., Inc. | 1990-05-24 |
| K897183 | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS | Beckman Instruments, Inc. | 1990-03-30 |
| K900420 | BICARBONATE REAGENTS PRODUCT #7713 & #7714 | American Research Products Co. | 1990-03-01 |
Legacy Summary#
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FDA Review#
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