FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA KIT, NEONATAL T4
K Number: K782103
·
Decision Jan 17, 1979
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
10
Review Days
33
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
- RIA KIT, NEONATAL T4
- K Number
- K782103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Laboratories, Inc.
- Date Received
- December 15, 1978
- Decision Date
- January 17, 1979
- Product Code
- CDX
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDX), ordered by most recent decision date.
ELECSYS T4 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVE THYROXINE RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DELFIA NEONATAL THYROXINE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXSYM(TM) TOTAL T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Serono Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Mar 2, 1984 | Substantially Equivalent |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | Mar 31, 1981 | Substantially Equivalent |
| K810625 | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- | Mar 27, 1981 | Substantially Equivalent |
| K792043 | PAP-CHECK RIA KIT | Oct 30, 1979 | Substantially Equivalent |
| K790679 | ESTRADIOL RIA KIT | May 23, 1979 | Substantially Equivalent |
| K790440 | PROGESTERONE | May 3, 1979 | Substantially Equivalent |
| K782143 | RIA KIT, GLUCOSE | Feb 22, 1979 | Substantially Equivalent |
| K781733 | RIA KIT, PREG-STAT | Dec 20, 1978 | Substantially Equivalent |
| K781285 | INSULIN RIA KIT | Aug 14, 1978 | Substantially Equivalent |