EA 65— 510(k) K812086

Substantially Equivalent

Surgipath

FDA 510(k) clearance K812086 for EA 65, Substantially Equivalent on 1981-08-13. Applicant: Surgipath. Device class: 1.

Clearance details

Applicant: Surgipath
Product code: Code HZJ
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1981-07-22
Decision date: 1981-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HZJ

K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-61984-10-02
K842735 — PAP STAIN EA-651984-09-11
K842739 — PAP STAIN, EA-361984-09-11
K842736 — PAP STAIN, OG-61984-08-17
K842738 — PAP STAIN EA-501984-08-17

More clearances from Surgipath

K820027 — MODIFIED EA 501982-02-04
K812940 — 10% NEUTRAL BUFFERED FORMALIN CONCENT1981-12-10
K812087 — EA 501981-08-13
K811825 — ORANGE G-61981-07-10
K811826 — EOSIN Y1981-07-10

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