FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMUN-TEST FT3
K Number: K962760
·
Decision Nov 29, 1996
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
340
Review Days
136
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Basic Information
- Device Name
- ENZYMUN-TEST FT3
- K Number
- K962760
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- July 16, 1996
- Decision Date
- November 29, 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.
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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OPTICOAT T3 EIA KIT
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ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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| K984372 | ELECSYS CALCHECK TROPONIN T | Dec 14, 1998 | Substantially Equivalent |
| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |