FDA 510(k) clearance · back to tracker

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT

Molecular Biosystems, Inc. cleared K873565 on 1988-05-13, decision: substantially equivalent

K-number

K873565

Sponsor

Molecular Biosystems, Inc.

Device

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT

Class

Class I

Decision

Substantially Equivalent

Decision date

1988-05-13

Product code

LIO

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.2900

Official FDA record

Open K873565on accessdata.fda.gov →

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

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

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Source

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