FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMX T3 ASSAY
K Number: K944808
·
Decision Dec 9, 1994
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
130
Review Days
71
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Basic Information
- Device Name
- IMX T3 ASSAY
- K Number
- K944808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organon Teknika Corp.
- Date Received
- September 29, 1994
- Decision Date
- December 9, 1994
- 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.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
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TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
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AIA-PACK FT3 ASSAY
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OPTICOAT T3 EIA KIT
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·Clinical Chemistry
ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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