SIGMA ELECTROLYTE BUFFER
FDA 510(k) clearance K933695 · decided 1993-10-22
Clearance details
- K-number
- K933695
- Device name
- SIGMA ELECTROLYTE BUFFER
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-29
- Decision date
- 1993-10-22
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- JFL
- Device class
- 2
- Regulation number
- 862.1160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, 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 |
|---|---|---|
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191298) | Abbott Point of Care, Inc. | 2020-02-07 |
| GENCHEM CO2 ACID REAGENT (K040975) | Genchem, Inc. | 2004-12-27 |
| MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (K014034) | Beckman Coulter, Inc. | 2001-12-18 |
| SIGMA DIAGNOSTICS CO2 ACID REAGENT (K963541) | Sigma Diagnostics, Inc. | 1996-10-24 |
| SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (K963538) | Sigma Diagnostics, Inc. | 1996-10-11 |
| SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (K963540) | Sigma Diagnostics, Inc. | 1996-09-27 |
| NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (K963005) | Nova Biomedical Corp. | 1996-08-23 |
| SIGMA ELECTROLYTE REFERENCE REAGENT (K933696) | Sigma Chemical Co. | 1994-01-03 |
| SIGMA CO2 ALKALINE BUFFER REAGENT (K933691) | Sigma Chemical Co. | 1993-12-17 |
| SIGMA CO2 ACID REAGENT (K933692) | Sigma Chemical Co. | 1993-12-09 |
| HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 (K925553) | Hichem Diagnostics | 1993-02-12 |
| HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 (K925552) | Hichem Diagnostics | 1993-02-12 |
Recalls involving this device
No recalls on record reference this clearance.