FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRICHINELLA SEROLOGY MICROTITER ELISA
K Number: K904613
·
Decision Mar 21, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
12
Review Days
161
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Basic Information
- Device Name
- TRICHINELLA SEROLOGY MICROTITER ELISA
- K Number
- K904613
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3850
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Lmd Laboratories
- Date Received
- October 11, 1990
- Decision Date
- March 21, 1991
- Product Code
- GPG
- 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 |
|---|---|---|---|
| GPG | Antigen, Latex Agglutination, Trichinella Spiralis | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GPG), ordered by most recent decision date.
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