FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SOMAS CHLORIDE ASSAY KIT
K Number: K833787
·
Decision Jan 11, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- SOMAS CHLORIDE ASSAY KIT
- K Number
- K833787
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Somas Medical Industries, Inc.
- Date Received
- October 31, 1983
- Decision Date
- January 11, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
Other Clearances by Somas Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862179 | SOMAS LIQUID URINE CONTROL | Jul 1, 1986 | Substantially Equivalent |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Jul 6, 1984 | Substantially Equivalent |
| K840486 | TOTAL BILIRUBIN REAGENT | Apr 25, 1984 | Substantially Equivalent |
| K840974 | SOMAS HUMAN SPINAL FLUID CONTROL | Apr 5, 1984 | Substantially Equivalent |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | Mar 12, 1984 | Substantially Equivalent |