FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACS:CENTAUR CEA
K Number: K981478
·
Decision Aug 12, 1998
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
20
Review Days
110
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
- ACS:CENTAUR CEA
- K Number
- K981478
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Diagnostics Corp.
- Date Received
- April 24, 1998
- Decision Date
- August 12, 1998
- Product Code
- DHX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHX), ordered by most recent decision date.
Access CEA
FDA 510(k)
FDA Class 2
·Immunology
VITROS Immunodiagnostic Products CEA Reagent Pack
FDA 510(k)
FDA Class 2
·Immunology
ADVIA Centaur CEA Assay
FDA 510(k)
FDA Class 2
·Immunology
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
FDA 510(k)
FDA Class 2
·Immunology
VIDAS CEA (S) ASSAY
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Chiron Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Aug 5, 1999 | Substantially Equivalent |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Jun 30, 1999 | Substantially Equivalent |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Jun 18, 1999 | Substantially Equivalent |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Oct 15, 1998 | Substantially Equivalent |
| K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY | Aug 12, 1998 | Substantially Equivalent |
| K981592 | ACS:CENTAUR AFP | Jul 7, 1998 | Substantially Equivalent |
| K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | Mar 3, 1998 | Substantially Equivalent |
| K974029 | ACS TOBRAMYCIN | Feb 12, 1998 | Substantially Equivalent |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | Dec 8, 1997 | Substantially Equivalent |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Aug 8, 1997 | Substantially Equivalent |