FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
K Number: K091815
·
Decision Nov 16, 2009
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
8
Review Days
151
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Basic Information
- Device Name
- SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
- K Number
- K091815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotest Medical Corp.
- Date Received
- June 18, 2009
- Decision Date
- November 16, 2009
- Product Code
- NBW
- 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Biotest Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | May 19, 2015 | Substantially Equivalent |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | Feb 21, 2014 | Substantially Equivalent |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | Jun 28, 2013 | Substantially Equivalent |
| K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM | May 2, 2013 | Substantially Equivalent |
| K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | May 12, 2010 | Substantially Equivalent |
| K100701 | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | Apr 8, 2010 | Substantially Equivalent |
| K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | Mar 2, 2010 | Substantially Equivalent |