FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
K Number: K992157
·
Decision Aug 5, 1999
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
20
Review Days
41
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Basic Information
- Device Name
- CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
- K Number
- K992157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Diagnostics Corp.
- Date Received
- June 25, 1999
- Decision Date
- August 5, 1999
- Product Code
- DBF
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Chiron Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |