FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEINS
K Number: K850936
·
Decision Jun 25, 1985
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
11
Review Days
110
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Basic Information
- Device Name
- TOTAL PROTEINS
- K Number
- K850936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dilab, Inc.
- Date Received
- March 7, 1985
- Decision Date
- June 25, 1985
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
HICHEM TOTAL PROTEIN REAGENT
FDA 510(k)
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·Clinical Chemistry
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN OR TP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CSF/URINE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Dilab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862530 | RAPID AS LATEX | Apr 21, 1987 | Substantially Equivalent |
| K850931 | ALBUMIN | Jun 26, 1985 | Substantially Equivalent |
| K850938 | CHOLESTEROL | 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 |