FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K Number: K951321
·
Decision Aug 24, 1995
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
319
Review Days
154
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 NEONATAL T4 ENZYME IMMUNOASSAY
- K Number
- K951321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Rad
- Date Received
- March 23, 1995
- Decision Date
- August 24, 1995
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLI), ordered by most recent decision date.
VITROS® Automation Solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GSP NEONATAL THYROXINE (T4)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS TOTAL T4 ASSAY
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 |