FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS THYROXINE (T4) ASSAY (T4)
K Number: K926393
·
Decision May 13, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
49
Review Days
143
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
- VIDAS THYROXINE (T4) ASSAY (T4)
- K Number
- K926393
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- December 21, 1992
- Decision Date
- May 13, 1993
- 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 Biomerieux Vitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Mar 10, 1998 | Substantially Equivalent |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Oct 3, 1997 | Substantially Equivalent |
| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 1997 | Substantially Equivalent |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Apr 8, 1997 | Substantially Equivalent |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Aug 30, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |