ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS— 510(k) K834242

Name: FDA 510(k) clearance K834242
Creator: U.S. Food and Drug Administration
Published: 1984-03-02

Substantially Equivalent

Apple Diagnostic Products

FDA 510(k) clearance K834242 for ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS, Substantially Equivalent on 1984-03-02. Applicant: Apple Diagnostic Products. Device class: 1.

Clearance details

Applicant: Apple Diagnostic Products
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1983-12-06
Decision date: 1984-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII1985-01-07
K843745 — ADP ANA APPLEZYME1984-10-25
K843120 — APPLELISA CHLAMYDIA TRACHOMATIS ANTI1984-09-12
K842707 — ADP NDNA IFA TEST1984-08-21
K842183 — ADP ANA IFA TEST1984-06-22

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