FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHASE II T3 RADIOIMMUNOASSAY KIT
K Number: K831064
·
Decision May 9, 1983
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
14
Review Days
35
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
- PHASE II T3 RADIOIMMUNOASSAY KIT
- K Number
- K831064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medical & Scientific Designs, Inc.
- Date Received
- April 4, 1983
- Decision Date
- May 9, 1983
- 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 Medical & Scientific Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT | Aug 27, 1986 | Substantially Equivalent |
| K853224 | PHASE II B-12/FOLATE KIT | Oct 3, 1985 | Substantially Equivalent |
| K840901 | PHASE II FREE T4 KIT | Apr 25, 1984 | Substantially Equivalent |
| K840328 | PHASE II HCG KIT | Apr 19, 1984 | Substantially Equivalent |
| K834219 | PHASE II CORTISOL KIT | Feb 4, 1984 | Substantially Equivalent |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Jan 24, 1984 | Substantially Equivalent |
| K832499 | PHASE II TSH KIT | Sep 12, 1983 | Substantially Equivalent |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | Aug 24, 1983 | Substantially Equivalent |
| K832210 | GAMMA PHOTON GAMMA COUNTER | Aug 24, 1983 | Substantially Equivalent |
| K830900 | UPTAKE T3 RADIOIMMUNOASSAY KIT | Apr 18, 1983 | Substantially Equivalent |