FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K Number: K903332
·
Decision Aug 17, 1990
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
98
Applicant Total
288
Review Days
23
Basic Information
- Device Name
- SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
- K Number
- K903332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- Date Received
- July 25, 1990
- Decision Date
- August 17, 1990
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFJ), ordered by most recent decision date.
Amylase2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Amylase_2 (AMY_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
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 |