FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T3 STI KIT
K Number: K780146
·
Decision Feb 23, 1978
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
3
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
- T3 STI KIT
- K Number
- K780146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Polysciences, Inc.
- Date Received
- January 30, 1978
- Decision Date
- February 23, 1978
- Product Code
- KHQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHQ), ordered by most recent decision date.
ACE T UPTAKE REAGENT TU CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T-UPTAKE MICROPLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHIRON DIAGNOSTICS ACS:180TU P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS T-UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CEDIA T UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry