LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574


definition

Device Classification Name

controls for blood-gases, (assayed and unassayed)

510(k) Number K002866
Device Name LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact elizabeth platt
Regulation Number 862.1660
Classification Product Code
JJS  
Date Received 09/13/2000
Decision Date 09/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No