DIACROM *PLG— 510(k) K832591

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K832591 for DIACROM *PLG, Substantially Equivalent on 1983-11-21. Applicant: Wellcome Diagnostics. Device class: 1.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code DDX
Device class: Class 1
Regulation: 21 CFR 866.5715
Advisory panel: Immunology
Date received: 1983-08-02
Decision date: 1983-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code DDX

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K854572 — COATEST PLASMINOGEN1986-02-26
K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY1985-05-08

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