TOTAL HEMOLYTIC COMPLEMENT TEST KIT
FDA 510(k) clearance K820005 · decided 1982-01-22
Clearance details
- K-number
- K820005
- Device name
- TOTAL HEMOLYTIC COMPLEMENT TEST KIT
- Applicant
- Meloy Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-04
- Decision date
- 1982-01-22
- Days to decision
- 18 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.