FDA 510(k) clearance · back to tracker

DIAGNOSTIC PRODUCTS CORP. RIA CONTROL

Diagnostic Products Corp. cleared K800813 on 1980-04-24, decision: substantially equivalent

K-number

K800813

Sponsor

Diagnostic Products Corp.

Device

DIAGNOSTIC PRODUCTS CORP. RIA CONTROL

Class

Class I

Decision

Substantially Equivalent

Decision date

1980-04-24

Product code

JJY

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1660

Official FDA record

Open K800813on 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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Drop K800813 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.

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Source

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