FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K Number: K980190
·
Decision Mar 6, 1998
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
27
Applicant Total
2
Review Days
45
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Basic Information
- Device Name
- ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
- K Number
- K980190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Corp.
- Date Received
- January 20, 1998
- Decision Date
- March 6, 1998
- Product Code
- MOI
- 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 |
|---|---|---|---|
| MOI | System, Test, Immunological, Antigen, Tumor | FDA class 2 | Immunology |
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Other Clearances by Chiron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981698 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Jul 10, 1998 | Substantially Equivalent |