FDA 510(k) clearance · back to tracker

IN VITRO DIAGNOSTIC STANDARDS

Supelco, Inc. cleared K802278 on 1980-11-24, decision: substantially equivalent

K-number

K802278

Sponsor

Supelco, Inc.

Device

IN VITRO DIAGNOSTIC STANDARDS

Class

Class I

Decision

Substantially Equivalent

Decision date

1980-11-24

Product code

DIF

Advisory committee

Clinical Toxicology

Medical specialty

Clinical Toxicology

Regulation number

862.3280

Official FDA record

Open K802278on 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 K802278 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.

Try the sandbox

Source

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