FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
K Number: K043245
·
Decision Apr 29, 2005
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
21
Review Days
157
Basic Information
- Device Name
- EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
- K Number
- K043245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EPS BIO TECHNOLOGY CORP.
- Date Received
- November 23, 2004
- Decision Date
- April 29, 2005
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K113243 | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM | Mar 28, 2012 | Substantially Equivalent |
| K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Dec 23, 2011 | Substantially Equivalent |
| K111728 | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Sep 16, 2011 | Substantially Equivalent |
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| K101037 | EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 | May 23, 2011 | Substantially Equivalent |