FDA 510(k) clearance · back to tracker

LEECO PRL-QUANT DIAGNOSTIC TEST KIT

Leeco Diagnostics, Inc. cleared K820039 on 1982-01-22, decision: substantially equivalent

K-number

K820039

Sponsor

Leeco Diagnostics, Inc.

Device

LEECO PRL-QUANT DIAGNOSTIC TEST KIT

Class

Class I

Decision

Substantially Equivalent

Decision date

1982-01-22

Product code

CFT

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1625

Official FDA record

Open K820039on 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 K820039 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.