FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGMA CO2 ACID REAGENT
K Number: K933692
·
Decision Dec 9, 1993
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
27
Applicant Total
231
Review Days
133
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SIGMA CO2 ACID REAGENT
- K Number
- K933692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sigma Chemical Co.
- Date Received
- July 29, 1993
- Decision Date
- December 9, 1993
- Product Code
- JFL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JFL | Ph Rate Measurement, Carbon-Dioxide | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFL), ordered by most recent decision date.
i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GENCHEM CO2 ACID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA DIAGNOSTICS CO2 ACID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Sigma Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K933694 | SIGMA GLUCOSE REAGENT | Nov 4, 1994 | Substantially Equivalent |
| K933678 | SIGMA CALCIUM REAGENT | Mar 11, 1994 | Substantially Equivalent |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Jan 3, 1994 | Substantially Equivalent |
| K933679 | SIGMA BUN REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | Dec 10, 1993 | Substantially Equivalent |
| K933695 | SIGMA ELECTROLYTE BUFFER | Oct 22, 1993 | Substantially Equivalent |
| K933697 | SIGMA CRE REAGENT | Oct 18, 1993 | Substantially Equivalent |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Oct 13, 1993 | Substantially Equivalent |
| K933702 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 | Oct 8, 1993 | Substantially Equivalent |