FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K Number: K060768
·
Decision Apr 21, 2006
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
23
Applicant Total
37
Review Days
30
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Basic Information
- Device Name
- PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
- K Number
- K060768
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Diabetes Care, Inc.
- Date Received
- March 22, 2006
- Decision Date
- April 21, 2006
- Product Code
- JIN
- 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 |
|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
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