FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K Number: K860726
·
Decision Apr 21, 1986
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
72
Applicant Total
55
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
- ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
- K Number
- K860726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Trace Scientific , Ltd.
- Date Received
- February 26, 1986
- Decision Date
- April 21, 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 Trace Scientific , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Sep 17, 1998 | Substantially Equivalent |
| K981123 | UREA | Apr 24, 1998 | Substantially Equivalent |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | Sep 27, 1996 | Substantially Equivalent |
| K961114 | AST INCORPORATING DST | May 23, 1996 | Substantially Equivalent |
| K961123 | ALT INCORPORATING DST | Apr 25, 1996 | Substantially Equivalent |
| K952488 | TRACE COBAS MIRA RANGE | Oct 13, 1995 | Substantially Equivalent |
| K932713 | TRACE TRANSFERRIN REAGENT | Sep 30, 1993 | Substantially Equivalent |
| K923322 | TRACE ALBUMIN-MR REAGENT | Sep 11, 1992 | Substantially Equivalent |
| K914731 | TRACE GAMMA GT-SS REAGENT | Nov 19, 1991 | Substantially Equivalent |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | Jul 17, 1991 | Substantially Equivalent |