FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GO GLUCOSE MONITORING SYSTEM
K Number: K991754
·
Decision Sep 8, 1999
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
7
Review Days
107
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Basic Information
- Device Name
- GO GLUCOSE MONITORING SYSTEM
- K Number
- K991754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lxn Corp.
- Date Received
- May 24, 1999
- Decision Date
- September 8, 1999
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Lxn Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K002688 | PERSONAL GLUCOSE CONTROL CHARTING SYSTEM | Feb 1, 2001 | Substantially Equivalent |
| K990942 | DUET II GLUCOSE CONTROL MONITORING SYSTEM | Aug 2, 1999 | Substantially Equivalent |
| K973140 | DUET GLUCOSE CONTROL MONITORING SYSTEM | Oct 31, 1997 | Substantially Equivalent |
| K962597 | LXN FRUCTOSAMINE TEST SYSTEM | Jun 13, 1997 | Substantially Equivalent |
| K960034 | LXN BLOOD GLUCOSE TEST SYSTEM | Jun 28, 1996 | Substantially Equivalent |
| K955629 | LXN FRUCTOSAMINE TEST | Mar 20, 1996 | Substantially Equivalent |