LUTEINIZING HORMONE DIRECT RIA KIT 125/I
FDA 510(k) clearance K811024 · decided 1981-05-08
Clearance details
- K-number
- K811024
- Device name
- LUTEINIZING HORMONE DIRECT RIA KIT 125/I
- Applicant
- Immunalysis Corporation
- Decision
- Substantially Equivalent
- Date received
- 1981-04-15
- Decision date
- 1981-05-08
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- CEP
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.