FDA 510(k) clearance · back to tracker

COMBO-FER IRON DIAGNOSTIC

Immuno Assay Corp. cleared K811954 on 1981-07-27, decision: substantially equivalent

K-number

K811954

Sponsor

Immuno Assay Corp.

Device

COMBO-FER IRON DIAGNOSTIC

Class

Class I

Decision

Substantially Equivalent

Decision date

1981-07-27

Product code

JQG

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1415

Official FDA record

Open K811954on 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.

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Source

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