ANA APPLELISA— 510(k) K834241

Substantially Equivalent

Apple Diagnostic Products

FDA 510(k) clearance K834241 for ANA APPLELISA, Substantially Equivalent on 1984-04-04. Applicant: Apple Diagnostic Products. Device class: 2.

Clearance details

Applicant: Apple Diagnostic Products
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1983-12-06
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHN

K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine2022-04-29
K172745 — ImmuGlo HEp-2 Elite IFA2018-06-05
K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM2016-07-28
K160265 — Image Navigator by Immuno Concepts2016-06-17
K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE2015-04-17

More clearances from Apple Diagnostic Products

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.