FDA 510(k) clearance · back to tracker

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT

Molecular Biosystems, Inc. cleared K874544 on 1988-08-12, decision: substantially equivalent

K-number

K874544

Sponsor

Molecular Biosystems, Inc.

Device

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT

Class

Class I

Decision

Substantially Equivalent

Decision date

1988-08-12

Product code

LGO

Advisory committee

Hematology

Medical specialty

Hematology

Regulation number

864.7675

Official FDA record

Open K874544on 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.

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Drop K874544 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.