FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K Number: K913921
·
Decision Nov 22, 1991
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
122
Applicant Total
288
Review Days
80
Basic Information
- Device Name
- ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
- K Number
- K913921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- Date Received
- September 3, 1991
- Decision Date
- November 22, 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.
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
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by EM DIAGNOSTIC SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Jan 27, 1994 | Substantially Equivalent |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Jan 13, 1994 | Substantially Equivalent |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935179 | EMDS ALBUMIN (ALB) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Dec 16, 1993 | Substantially Equivalent |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Dec 16, 1993 | Substantially Equivalent |
| K935175 | LACTATE DEHYDROGENASE (LD) | Dec 16, 1993 | Substantially Equivalent |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Dec 16, 1993 | Substantially Equivalent |
| K935176 | IRON TEST | Dec 16, 1993 | Substantially Equivalent |
| K935183 | EMDS MAGNESIUM (MG) TEST | Dec 9, 1993 | Substantially Equivalent |