FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINIMUM ESSENTIAL MED W/L-GLUTAMINE
K Number: K842776
·
Decision Aug 20, 1984
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
366
Applicant Total
231
Review Days
35
Basic Information
- Device Name
- MINIMUM ESSENTIAL MED W/L-GLUTAMINE
- K Number
- K842776
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- SIGMA CHEMICAL CO.
- Date Received
- July 16, 1984
- Decision Date
- August 20, 1984
- Product Code
- KIT
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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|---|---|---|---|
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| K933679 | SIGMA BUN REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Dec 17, 1993 | Substantially Equivalent |
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| 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 |