HUMAN IGG-ALBUMIN TEST KIT
FDA 510(k) clearance K811178 · decided 1981-05-15
Clearance details
- K-number
- K811178
- Device name
- HUMAN IGG-ALBUMIN TEST KIT
- Applicant
- Meloy Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-28
- Decision date
- 1981-05-15
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- CJQ
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.