DNA FLOR— 510(k) K831408

Substantially Equivalent

Medastat Scientific Corp.

FDA 510(k) clearance K831408 for DNA FLOR, Substantially Equivalent on 1983-07-28. Applicant: Medastat Scientific Corp.. Device class: 2.

Clearance details

Applicant: Medastat Scientific Corp.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1983-05-02
Decision date: 1983-07-28
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 Medastat Scientific Corp.

K931849 — PARAPREP1993-12-02
K822604 — ACID FAST QUALITY CONTROL SLIDES1982-09-28

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