FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KINETIC ALKALINE PHOSPHATASE DETERMINATION
K Number: K905650
·
Decision Feb 13, 1991
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
20
Review Days
57
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
- KINETIC ALKALINE PHOSPHATASE DETERMINATION
- K Number
- K905650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biochemical Trade, Inc.
- Date Received
- December 18, 1990
- Decision Date
- February 13, 1991
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CJE), ordered by most recent decision date.
Tru Liver Health Test Panel
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alkaline Phosphatase
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alkaline Phosphatase2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Yumizen C1200 ALP, Yumizen C1200 Albumin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALP IFCC Gen.2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Biochemical Trade, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Nov 21, 1994 | Substantially Equivalent |
| K910635 | TOTAL BILIRUBIN REAGENT SET | May 15, 1991 | Substantially Equivalent |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Feb 27, 1991 | Substantially Equivalent |
| K905776 | ALBUMIN REAGENT SET | Feb 26, 1991 | Substantially Equivalent |
| K905790 | TOTAL PROTEIN REAGENT SET | Feb 21, 1991 | Substantially Equivalent |
| K905619 | CREATININE (RATE) REAGENT SET | Feb 13, 1991 | Substantially Equivalent |
| K905651 | KINETIC AMYLASE DETERMINATION | Jan 31, 1991 | Substantially Equivalent |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Jan 30, 1991 | Substantially Equivalent |
| K905588 | CREATINE KINASE UV REAGENT SET | Jan 17, 1991 | Substantially Equivalent |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | Jun 22, 1987 | Substantially Equivalent |