FDA 510(k) clearance · back to tracker

UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Bayer Corp. cleared K974721 on 1998-03-03, decision: substantially equivalent

K-number

K974721

Sponsor

Bayer Corp.

Device

UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Class

Class I

Decision

Substantially Equivalent

Decision date

1998-03-03

Product code

CGI

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1265

Official FDA record

Open K974721on 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 K974721 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.