DECALCIFIER II— 510(k) K810836

Substantially Equivalent

Surgipath

FDA 510(k) clearance K810836 for DECALCIFIER II, Substantially Equivalent on 1981-04-23. Applicant: Surgipath. Device class: 1.

Clearance details

Applicant: Surgipath
Product code: Code KDX
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1981-03-26
Decision date: 1981-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDX

K872625 — DECALCIFYING SOLUTION1987-08-06
K850636 — SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E1985-03-20
K842726 — DECALCIFIER SOLUTION1984-08-03
K841488 — DECALCIFIER I1984-05-02
K822036 — VOLU-SOL DECALCIFER1982-08-03

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.