FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLORIMETRIC DETERM. SOCITRATE DEHYDRO.
K Number: K770902
·
Decision Jul 14, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
231
Review Days
59
Basic Information
- Device Name
- COLORIMETRIC DETERM. SOCITRATE DEHYDRO.
- K Number
- K770902
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1420
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- SIGMA CHEMICAL CO.
- Date Received
- May 16, 1977
- Decision Date
- July 14, 1977
- Product Code
- JKH
- 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 |
|---|---|---|---|
| JKH | Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen | FDA class 1 | 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 |
| K933692 | SIGMA CO2 ACID REAGENT | Dec 9, 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 |