FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K Number: K850368
·
Decision Aug 30, 1985
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
23
Applicant Total
231
Review Days
211
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Basic Information
- Device Name
- SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
- K Number
- K850368
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- January 31, 1985
- Decision Date
- August 30, 1985
- Product Code
- JIN
- 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 |
|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 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 |