FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1-125 LABELED TRIIODOTHYRONINE(T3)
K Number: K803180
·
Decision Jan 9, 1981
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
29
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 1-125 LABELED TRIIODOTHYRONINE(T3)
- K Number
- K803180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pcl-Ria, Inc.
- Date Received
- December 16, 1980
- Decision Date
- January 9, 1981
- 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)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHIRON DIAGNOSTICS ACS: 180 FT3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AIA-PACK FT3 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTICOAT T3 EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Pcl-Ria, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830526 | B-GCG SYSTEM BY RIA | Apr 5, 1983 | Substantially Equivalent |
| K822935 | THYROID STIMULATING HORMONE | Nov 1, 1982 | Substantially Equivalent |
| K823014 | DIGOXIN KIT | Nov 1, 1982 | Substantially Equivalent |
| K822612 | T3 UPTAKE KITS | Sep 30, 1982 | Substantially Equivalent |
| K820886 | THYROXINE T4 KIT | Apr 16, 1982 | Substantially Equivalent |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Mar 26, 1982 | Substantially Equivalent |
| K820357 | LUTEINIZING HORMONE KIT | Mar 25, 1982 | Substantially Equivalent |
| K812666 | THYROXINE (T4) 125I | Oct 2, 1981 | Substantially Equivalent |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | Apr 14, 1981 | Substantially Equivalent |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Apr 8, 1981 | Substantially Equivalent |