WELLCOGEN H. INFLUENZAL ZL21
FDA 510(k) clearance K833077 · decided 1984-01-10
Clearance details
- K-number
- K833077
- Device name
- WELLCOGEN H. INFLUENZAL ZL21
- Applicant
- Wellcome Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1983-09-09
- Decision date
- 1984-01-10
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- GRD
- Device class
- 1
- Regulation number
- 866.3380
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.