RADIOIMMUNOASSAY TEST SYSTEM PRL— 510(k) K830412

Substantially Equivalent

Monobind

FDA 510(k) clearance K830412 for RADIOIMMUNOASSAY TEST SYSTEM PRL, Substantially Equivalent on 1983-04-05. Applicant: Monobind. Device class: 1.

Clearance details

Applicant: Monobind
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1983-02-08
Decision date: 1983-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.