FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACS:CENTAUR PSA2 IMMUNOASSAY
K Number: K981839
·
Decision Aug 12, 1998
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
20
Review Days
78
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Basic Information
- Device Name
- ACS:CENTAUR PSA2 IMMUNOASSAY
- K Number
- K981839
- 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
- May 26, 1998
- Decision Date
- August 12, 1998
- Product Code
- LTJ
- 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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LTJ), ordered by most recent decision date.
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FREND PSA PLUS (REAGENT CARTRIDGE)
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TPSA FLEX REAGENT CARTRIDGE
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COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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 |
| K981478 | ACS:CENTAUR CEA | 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 |