FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALBUMIN
K Number: K850931
·
Decision Jun 26, 1985
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
11
Review Days
111
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Basic Information
- Device Name
- ALBUMIN
- K Number
- K850931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dilab, Inc.
- Date Received
- March 7, 1985
- Decision Date
- June 26, 1985
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Dilab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862530 | RAPID AS LATEX | Apr 21, 1987 | Substantially Equivalent |
| K850938 | CHOLESTEROL | Jun 25, 1985 | Substantially Equivalent |
| K850936 | TOTAL PROTEINS | Jun 25, 1985 | Substantially Equivalent |
| K850932 | CREATININE | Jun 25, 1985 | Substantially Equivalent |
| K850933 | URIC ACID | Jun 25, 1985 | Substantially Equivalent |
| K850934 | PHOSPHORUS | Jun 25, 1985 | Substantially Equivalent |
| K850935 | CHLORIDE | Jun 10, 1985 | Substantially Equivalent |
| K850937 | UREA | Jun 10, 1985 | Substantially Equivalent |
| K850930 | GLUCOSE | Jun 10, 1985 | Substantially Equivalent |
| K850929 | CALCIUM | Jun 10, 1985 | Substantially Equivalent |