FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRACHEM GLUC-DH
K Number: K813427
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
72
Applicant Total
116
Review Days
24
Basic Information
- Device Name
- ULTRACHEM GLUC-DH
- K Number
- K813427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- HARLECO
- Date Received
- December 7, 1981
- Decision Date
- December 31, 1981
- 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 HARLECO
| K Number | Device Name | ||
|---|---|---|---|
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | Feb 12, 1982 | Substantially Equivalent |
| K813043 | ULTRACHEM CREA ITEM #64972 | Nov 10, 1981 | Substantially Equivalent |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Nov 10, 1981 | Substantially Equivalent |
| K813038 | ULTRACHEM TP, ITEM #64974 | Nov 10, 1981 | Substantially Equivalent |
| K813044 | ULTRACHEM ALB, ITEM #64970 | Nov 10, 1981 | Substantially Equivalent |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | Nov 10, 1981 | Substantially Equivalent |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Nov 10, 1981 | Substantially Equivalent |
| K813040 | ULTRACHEM CA, ITEM #64975 | Nov 10, 1981 | Substantially Equivalent |
| K812593 | ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 | Oct 2, 1981 | Substantially Equivalent |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | Oct 2, 1981 | Substantially Equivalent |