FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K Number: K990424
·
Decision Mar 31, 1999
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
672
Applicant Total
318
Review Days
48
Basic Information
- Device Name
- ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
- K Number
- K990424
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIO-RAD
- Date Received
- February 11, 1999
- Decision Date
- March 31, 1999
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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