FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K Number: K874375
·
Decision Dec 10, 1987
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
883
Review Days
45
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Basic Information
- Device Name
- ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
- K Number
- K874375
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- October 26, 1987
- Decision Date
- December 10, 1987
- Product Code
- LIQ
- 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 |
|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | FDA class 1 | Microbiology |
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