FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAS FREE T4 ENZYME IMMUNOASSAY
K Number: K931110
·
Decision May 20, 1993
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
319
Review Days
78
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
- RADIAS FREE T4 ENZYME IMMUNOASSAY
- K Number
- K931110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Rad
- Date Received
- March 3, 1993
- Decision Date
- May 20, 1993
- Product Code
- CEC
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEC), ordered by most recent decision date.
Access Free T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys FT4 IV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGLUMI 2000 FT4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys FT4 III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Abbott Architect Free T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREND Free T4 Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Bio-Rad
| K Number | Device Name | ||
|---|---|---|---|
| K171061 | MRSASelect II | Dec 28, 2017 | Substantially Equivalent |
| K122187 | VRESELECT CULTURE MEDIUM | Nov 6, 2012 | Substantially Equivalent |
| K103684 | VRESELECT CULTURE MEDIUM | Oct 21, 2011 | Substantially Equivalent |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Jan 13, 2011 | Substantially Equivalent |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent |
| K081362 | PLATELIA LYME IGM | Jun 26, 2008 | Substantially Equivalent |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Jun 13, 2008 | Substantially Equivalent |
| K080012 | PLATELIA LYME IGG ASSAY | May 8, 2008 | Substantially Equivalent |
| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | Jun 2, 2006 | Substantially Equivalent |