IMMPULSE TBC ASSAY REAGENTS— 510(k) K840853

Name: FDA 510(k) clearance K840853
Creator: U.S. Food and Drug Administration
Published: 1984-04-01

Substantially Equivalent

Paragon Diagnostics, Inc.

FDA 510(k) clearance K840853 for IMMPULSE TBC ASSAY REAGENTS, Substantially Equivalent on 1984-04-01. Applicant: Paragon Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Paragon Diagnostics, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1984-02-24
Decision date: 1984-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

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K840758 — IMMPULSE THEOPHYLLINE ASSAY REAGENTS1984-04-04
K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS1984-04-04

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