FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRIA T4 RIA
K Number: K761272
·
Decision Mar 16, 1977
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
8
Review Days
86
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Basic Information
- Device Name
- CENTRIA T4 RIA
- K Number
- K761272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Diagnostics, Inc.
- Date Received
- December 20, 1976
- Decision Date
- March 16, 1977
- 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
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ACTIVE THYROXINE RIA
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AXSYM(TM) TOTAL T4
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TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
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FDA Class 2
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STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Clinical Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971653 | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM | Jan 2, 1998 | Substantially Equivalent |
| K951457 | GLUCOCHEK POCKETLAB | Feb 22, 1996 | Substantially Equivalent |
| K940215 | GLUCOCHEK | Jan 17, 1995 | Substantially Equivalent |
| K854903 | GORDON DIAGNOSTIC SYSTEM MODEL I | Jun 2, 1986 | Substantially Equivalent |
| K771813 | CENTRIFICHEM SYS 400 ANALYZER | Oct 25, 1977 | Substantially Equivalent |
| K771118 | CENTRIA SEPARATION COLUMNS TYPE A | Jul 11, 1977 | Substantially Equivalent |
| K771117 | CENTRIA CORTISOL RIA | Jun 23, 1977 | Substantially Equivalent |