FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TWO MINUTE PROTEINTEST
K Number: K792346
·
Decision Dec 6, 1979
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
16
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TWO MINUTE PROTEINTEST
- K Number
- K792346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Panmed, Inc.
- Date Received
- November 19, 1979
- Decision Date
- December 6, 1979
- 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 Panmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852767 | ERYTHOCYTE CREATINE | Nov 13, 1986 | Substantially Equivalent |
| K820642 | SICKLE-CHECK | Apr 14, 1982 | Substantially Equivalent |
| K802155 | REAGENTS SERUM SODIUM USING THE TECH. | Oct 10, 1980 | Substantially Equivalent |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | Oct 10, 1980 | Substantially Equivalent |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802156 | REAGENTS SERUM CREATINE USING TECHICON | Oct 10, 1980 | Substantially Equivalent |
| K802163 | CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802157 | BCG REAGENT SERUM ALBUMIN W/TECHNICON | Oct 10, 1980 | Substantially Equivalent |
| K802159 | AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS | Oct 10, 1980 | Substantially Equivalent |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Oct 10, 1980 | Substantially Equivalent |