THC DIRECT RIA KIT
FDA 510(k) clearance K781048 · decided 1978-10-03
Clearance details
- K-number
- K781048
- Device name
- THC DIRECT RIA KIT
- Applicant
- Immunalysis Corporation
- Decision
- Substantially Equivalent
- Date received
- 1978-06-21
- Decision date
- 1978-10-03
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- LAT
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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.