FDA 510(k) clearance · back to tracker

TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM

Miles, Inc. cleared K950353 on 1995-04-20, decision: substantially equivalent

K-number

K950353

Sponsor

Miles, Inc.

Device

TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

1995-04-20

Product code

JJE

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.2160

Official FDA record

Open K950353on 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 K950353 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.