EOSIN Y— 510(k) K811826

Substantially Equivalent

Surgipath

FDA 510(k) clearance K811826 for EOSIN Y, Substantially Equivalent on 1981-07-10. Applicant: Surgipath. Device class: 1.

Clearance details

Applicant: Surgipath
Product code: Code HYB
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1981-06-29
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HYB

K893663 — INSTANT EOSIN-AQUEOUS1989-06-13
K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE1988-03-31
K880240 — INSTANT EOSIN-ALCOHOLIC1988-03-03
K843426 — EOSIN Y 1% ALCOHOLIC1984-09-27
K822982 — MIDAS 100 HEMACOLOR STAIN #660301982-10-27

More clearances from Surgipath

K820027 — MODIFIED EA 501982-02-04
K812940 — 10% NEUTRAL BUFFERED FORMALIN CONCENT1981-12-10
K812086 — EA 651981-08-13
K812087 — EA 501981-08-13
K811825 — ORANGE G-61981-07-10

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