FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES— 510(k) K844346
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K844346 for FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES, Substantially Equivalent on 1985-03-04. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.