REPTILASE-R HA35— 510(k) K840210

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K840210 for REPTILASE-R HA35, Substantially Equivalent on 1984-04-23. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code JCO
Device class: Class 2
Regulation: 21 CFR 864.8100
Advisory panel: Hematology
Date received: 1984-01-19
Decision date: 1984-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K843207 — REPTILASE -PC1984-10-23

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