MICROHEMATOCRIT READER— 510(k) K830578

Name: FDA 510(k) clearance K830578
Creator: U.S. Food and Drug Administration
Published: 1983-03-24

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K830578 for MICROHEMATOCRIT READER, Substantially Equivalent on 1983-03-24. Applicant: Fisher Scientific Co., LLC. Device class: 2.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1983-02-23
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPI

view all

K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System2020-02-28
K163342 — i-STAT Hematocrit test with i-STAT Alinity System2017-08-22
K950942 — CRIT-LINE HEMATOCRIT ALERT1995-03-14
K924167 — CRIT-LINE1993-05-07
K903698 — STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES1990-09-17

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.