FDA 510(k) clearance · back to tracker

LUMATAG(TM) LH DIAGNOSTIC KIT

London Diagnostics, Inc. cleared K902443 on 1990-08-02, decision: substantially equivalent

K-number

K902443

Sponsor

London Diagnostics, Inc.

Device

LUMATAG(TM) LH DIAGNOSTIC KIT

Class

Class I

Decision

Substantially Equivalent

Decision date

1990-08-02

Product code

CEP

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1485

Official FDA record

Open K902443on 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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Source

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