ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

Multi-analyte Controls, All Kinds (assayed)

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Architect Free Psa Mastercheck, Model 6c07-05; Architect Tital Psa Mastercheck, Model 6c06-05.

Pre-market Notification Details

Device IDK042335
510k NumberK042335
Device Name:ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactMaria Zeballos
CorrespondentMaria Zeballos
BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-30
Decision Date2004-09-17
Summary:summary

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