Source document or public record
FDA 510(k) K193204 — Cryocheck Chromogenic Factor VIII
FDA 510(k) index record K193204. Device: Cryocheck Chromogenic Factor VIII. Applicant as listed: Precision Biologic. Decision date: 2020-07-17.
Source
"device_name": "Cryocheck Chromogenic Factor VIII"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K193204.
Device name: Cryocheck Chromogenic Factor VIII. Applicant as listed: Precision Biologic.
Decision date: 2020-07-17. Decision wording: Substantially Equivalent.
Product code: GGP. Regulation: 21 CFR 864.7290. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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