FDA 510(k) clearance · back to tracker

TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

Bayer Corp. cleared K963080 on 1996-09-27, decision: substantially equivalent

K-number

K963080

Sponsor

Bayer Corp.

Device

TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

Class

Class I

Decision

Substantially Equivalent

Decision date

1996-09-27

Product code

CDZ

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1680

Official FDA record

Open K963080on 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 K963080 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.