FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T3 RIA TEST SYSTEM
K Number: K771220
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
21
Review Days
30
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Basic Information
- Device Name
- T3 RIA TEST SYSTEM
- K Number
- K771220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Monobind
- Date Received
- July 5, 1977
- Decision Date
- August 4, 1977
- 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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ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Monobind
| K Number | Device Name | ||
|---|---|---|---|
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Aug 22, 2003 | Substantially Equivalent |
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | Apr 5, 2002 | Substantially Equivalent |
| K980088 | T-UPTAKE MICROPLATE EIA | Feb 4, 1998 | Substantially Equivalent |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Sep 2, 1997 | Substantially Equivalent |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Jul 3, 1997 | Substantially Equivalent |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Jul 3, 1997 | Substantially Equivalent |
| K971780 | THYROTROPIN(TSH) ELISA | Jun 24, 1997 | Substantially Equivalent |
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Jun 24, 1997 | Substantially Equivalent |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Jun 16, 1997 | Substantially Equivalent |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Jun 16, 1997 | Substantially Equivalent |