FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
K Number: K980574
·
Decision Mar 24, 1998
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
3
Review Days
35
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Basic Information
- Device Name
- AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
- K Number
- K980574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alfa Biotech (Uk) , Ltd.
- Date Received
- February 17, 1998
- Decision Date
- March 24, 1998
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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