FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINIFUGE, MODEL 70
K Number: K882149
·
Decision Jul 1, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
1
Review Days
39
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Basic Information
- Device Name
- MINIFUGE, MODEL 70
- K Number
- K882149
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3850
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Utah Bioresearch, Inc.
- Date Received
- May 23, 1988
- Decision Date
- July 1, 1988
- Product Code
- GPG
- Advisory Committee
- Microbiology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GPG | Antigen, Latex Agglutination, Trichinella Spiralis | FDA class 1 | Microbiology |
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