FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
K Number: K800679
·
Decision May 28, 1980
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
26
Review Days
63
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
- REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
- K Number
- K800679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Solutions, Inc.
- Date Received
- March 26, 1980
- Decision Date
- May 28, 1980
- 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 Diagnostic Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | Jan 11, 1994 | Substantially Equivalent |
| K924398 | UNI-CHECK REAGENT STRIP | Dec 23, 1992 | Substantially Equivalent |
| K921825 | QUICK-CHECK II REAGENT STRIP | Aug 18, 1992 | Substantially Equivalent |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | May 30, 1980 | Substantially Equivalent |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | May 30, 1980 | Substantially Equivalent |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | May 28, 1980 | Substantially Equivalent |
| K800674 | SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER | May 28, 1980 | Substantially Equivalent |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | May 28, 1980 | Substantially Equivalent |
| K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU | May 28, 1980 | Substantially Equivalent |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | May 28, 1980 | Substantially Equivalent |