HEMATOLOGY STAIN PACK— 510(k) K853241

Name: FDA 510(k) clearance K853241
Creator: U.S. Food and Drug Administration
Published: 1985-08-19

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K853241 for HEMATOLOGY STAIN PACK, Substantially Equivalent on 1985-08-19. Applicant: Fisher Scientific Co., LLC. Device class: 1.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code IAF
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1985-08-01
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fair Lawn, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IAF

view all

K890673 — WRIGHT-GLEMSA STAIN1989-02-24
K890674 — ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET1989-02-24
K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS1986-10-10
K860793 — CAMCO STAIN PAK1986-03-18
K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S1985-06-13

More clearances from Fisher Scientific Co., LLC

view all

K930415 — MICROHEMATOCRIT ROTOR1993-03-23
K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE1992-03-11
K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE1992-01-08
K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 11989-03-08
K881275 — URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II1988-05-16

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