PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED— 510(k) K884517

Name: FDA 510(k) clearance K884517
Creator: U.S. Food and Drug Administration
Published: 1988-11-30

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K884517 for PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED, Substantially Equivalent on 1988-11-30. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1988-10-27
Decision date: 1988-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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