PACIFIC HEMOSTASIS REFERENCE EMULSION— 510(k) K013397
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K013397 for PACIFIC HEMOSTASIS REFERENCE EMULSION, Substantially Equivalent on 2002-02-15. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middletown, VA, US
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- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.