IMMULON 1, #11-010-3350 & IMMULON 2 #--
FDA 510(k) clearance K801018 · decided 1980-05-14
Clearance details
- K-number
- K801018
- Device name
- IMMULON 1, #11-010-3350 & IMMULON 2 #--
- Applicant
- Dynatech Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-30
- Decision date
- 1980-05-14
- Days to decision
- 14 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.