FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIURET (COLORMETRIC), TOTAL PROTEIN
K Number: K901527
·
Decision Jul 19, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
115
Applicant Total
56
Review Days
108
Basic Information
- Device Name
- BIURET (COLORMETRIC), TOTAL PROTEIN
- K Number
- K901527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN RESEARCH PRODUCTS CO.
- Date Received
- April 2, 1990
- Decision Date
- July 19, 1990
- 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
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TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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CARESIDE TOTAL PROTEIN
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TOTAL PROTEIN OR TP
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CSF/URINE TOTAL PROTEIN
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STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by AMERICAN RESEARCH PRODUCTS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K942984 | BUN REAGENT | Mar 1, 1995 | Substantially Equivalent |
| K901964 | PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 | May 31, 1990 | Substantially Equivalent |
| K901960 | IRON REAGENTS PRODUCT CODES 7725 AND 7726 | May 31, 1990 | Substantially Equivalent |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | May 2, 1990 | Substantially Equivalent |
| K901702 | NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 | Apr 25, 1990 | Substantially Equivalent |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | Apr 19, 1990 | Substantially Equivalent |
| K900666 | AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 | Apr 19, 1990 | Substantially Equivalent |
| K900571 | AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) | Apr 16, 1990 | Substantially Equivalent |
| K900394 | AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 | Apr 11, 1990 | Substantially Equivalent |
| K900977 | AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 | Apr 11, 1990 | Substantially Equivalent |