GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6— 510(k) K843427

Name: FDA 510(k) clearance K843427
Creator: U.S. Food and Drug Administration
Published: 1984-10-02

Substantially Equivalent

Accra Laboratories, Inc.

FDA 510(k) clearance K843427 for GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6, Substantially Equivalent on 1984-10-02. Applicant: Accra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Accra Laboratories, Inc.
Product code: Code HZJ
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1984-09-04
Decision date: 1984-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HZJ

view all

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
K840054 — PAPANICOLAOU STAIN SYS HT401984-02-17

More clearances from Accra Laboratories, Inc.

view all

K851493 — KINYOUN ACID FAST STAIN KIT1985-04-29
K851494 — TWO-STEP ACID FAST BACTERIA STAIN1985-04-29
K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID1984-10-02
K843426 — EOSIN Y 1% ALCOHOLIC1984-09-27
K843428 — BIOFIX1984-09-27

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