CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
FDA 510(k) clearance K873625 · decided 1987-10-20
Clearance details
- K-number
- K873625
- Device name
- CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-08
- Decision date
- 1987-10-20
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JLM
- Device class
- 2
- Regulation number
- 864.7360
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Berkshire, England, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.