FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REAGENT SYSTEM, INORGANIC PHOSPHORUS
K Number: K781806
·
Decision Jan 17, 1979
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
231
Review Days
84
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Basic Information
- Device Name
- REAGENT SYSTEM, INORGANIC PHOSPHORUS
- K Number
- K781806
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- October 25, 1978
- Decision Date
- January 17, 1979
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
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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 |