FDA 510(k) clearance · back to tracker

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE

Tech Intl. Co. cleared K914171 on 1991-12-18, decision: substantially equivalent

K-number

K914171

Sponsor

Tech Intl. Co.

Device

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE

Class

Class I

Decision

Substantially Equivalent

Decision date

1991-12-18

Product code

DIH

Advisory committee

Clinical Toxicology

Medical specialty

Clinical Toxicology

Regulation number

862.3240

Official FDA record

Open K914171on 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 K914171 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.