FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
K Number: K033603
·
Decision Dec 19, 2003
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
270
Review Days
32
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Basic Information
- Device Name
- INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
- K Number
- K033603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- November 17, 2003
- Decision Date
- December 19, 2003
- Product Code
- LIG
- 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 |
|---|---|---|---|
| LIG | Radioassay, Intrinsic Factor Blocking Antibody | FDA class 2 | Clinical Chemistry |
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