ABURIA-CK RIA TEST KIT
FDA 510(k) clearance K813087 · decided 1981-12-17
Clearance details
- K-number
- K813087
- Device name
- ABURIA-CK RIA TEST KIT
- Applicant
- Intl. Immunoassay Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-02
- Decision date
- 1981-12-17
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- JHX
- Device class
- 2
- Regulation number
- 862.1215
- 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.