FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT CHAGAS ANTIBODY EIA
K Number: K933716
·
Decision Dec 19, 1994
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
5
Applicant Total
883
Review Days
507
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Basic Information
- Device Name
- ABBOTT CHAGAS ANTIBODY EIA
- K Number
- K933716
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3870
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- July 30, 1993
- Decision Date
- December 19, 1994
- Product Code
- MIU
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | FDA class 1 | Microbiology |
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