FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K Number: K760134
·
Decision Jul 20, 1976
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
24
Applicant Total
319
Review Days
22
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
- PROCEDURE, RA, THYROXINE BINDING PROTEIN
- K Number
- K760134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1685
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- June 28, 1976
- Decision Date
- July 20, 1976
- Product Code
- CEE
- 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 |
|---|---|---|---|
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEE), ordered by most recent decision date.
AMERLITE TBG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS THYROID UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMULITE(TM) T-UPTAKE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DELFIA TBG KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENZYMUN TEST(R) TBK
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 |