FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMDS GLUCOSE TEST PACK ITEM 67656/95
K Number: K855080
·
Decision Feb 11, 1986
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
72
Applicant Total
288
Review Days
54
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
- EMDS GLUCOSE TEST PACK ITEM 67656/95
- K Number
- K855080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Em Diagnostic Systems, Inc.
- Date Received
- December 19, 1985
- Decision Date
- February 11, 1986
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFR), ordered by most recent decision date.
FreeStyle InsuLinx Blood Glucose Monotioring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK AVIVA EXPERT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
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 |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | 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 |
| K935176 | IRON TEST | Dec 16, 1993 | Substantially Equivalent |
| K935183 | EMDS MAGNESIUM (MG) TEST | Dec 9, 1993 | Substantially Equivalent |