FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T-3 MICROWELL EIA MODEL 7013
K Number: K960412
·
Decision Mar 19, 1996
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
10
Review Days
50
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Basic Information
- Device Name
- T-3 MICROWELL EIA MODEL 7013
- K Number
- K960412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerica, Inc.
- Date Received
- January 29, 1996
- Decision Date
- March 19, 1996
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
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ABBOTT ARCHITECT FREE T3
FDA 510(k)
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| K962216 | TSH (MICROWELL) ELISA | Sep 19, 1996 | Substantially Equivalent |
| K954256 | ANTI-TPO | Nov 27, 1995 | Substantially Equivalent |
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| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Jul 18, 1994 | Substantially Equivalent |
| K915185 | GAP IGG H.PYLORI MODIFIED | Mar 4, 1992 | Substantially Equivalent |
| K900343 | GAP-IGG | Aug 22, 1991 | Substantially Equivalent |