510(k) K873625
- Device
- CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
- Applicant
- BOOTS-CELLTECH DIAGNOSTICS, INC.
- 510(k) number
- K873625
- Product code
- JLM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-20
- Date received
- 1987-09-08
- Regulation
- 864.7360
- Classification name
- Isoenzymes, Electrophoretic, Glucose-6-phosphate Dehydrogenase
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN SIMPSON
- Address
- 240 Bath Rd. Slough Sl1 4et Berkshire, England GB
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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