FDA 510(k) clearance · back to tracker

Babio® Virus Transport Kit (Non-inactivating)

Jinan Babio Biotechnology Co., Ltd. cleared K250205 on 2025-09-22, decision: substantially equivalent

K-number

K250205

Sponsor

Jinan Babio Biotechnology Co., Ltd.

Device

Babio® Virus Transport Kit (Non-inactivating)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-09-22

Product code

JSM

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.2390

Official FDA record

Open K250205on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K250205 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.