EMBRIA-CK
FDA 510(k) clearance K801728 · decided 1980-09-26
Clearance details
- K-number
- K801728
- Device name
- EMBRIA-CK
- Applicant
- Intl. Immunoassay Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-24
- Decision date
- 1980-09-26
- Days to decision
- 64 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.