FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN TEST
K Number: K801061
·
Decision Jul 21, 1980
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
15
Review Days
76
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Basic Information
- Device Name
- TOTAL PROTEIN TEST
- K Number
- K801061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Environmental Chemical Specialties
- Date Received
- May 6, 1980
- Decision Date
- July 21, 1980
- 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)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
FDA 510(k)
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 Environmental Chemical Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K812635 | ANEMIA CONTROL | Oct 2, 1981 | Substantially Equivalent |
| K811810 | URIC ACID TEST | Jul 15, 1981 | Substantially Equivalent |
| K811809 | ANTI-ARRHYTHMIC CONTROL LEVELS I & II | Jul 10, 1981 | Substantially Equivalent |
| K811811 | TDM ANTI-CONVULSANT CONTROL LEVELS I-II | Jul 10, 1981 | Substantially Equivalent |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Jan 2, 1981 | Substantially Equivalent |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Sep 26, 1980 | Substantially Equivalent |
| K801854 | SPINAL FLUID CONTROL(HUMAN) | Sep 16, 1980 | Substantially Equivalent |
| K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) | Dec 6, 1979 | Substantially Equivalent |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | Dec 6, 1979 | Substantially Equivalent |
| K792375 | ELEVATED LIPID CONTROL | Dec 6, 1979 | Substantially Equivalent |