LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO

Multi-analyte Controls, All Kinds (assayed)

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige Co.

Pre-market Notification Details

Device IDK134013
510k NumberK134013
Device Name:LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant Bio-Rad Laboratories 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactSuzanne Parsons
CorrespondentSuzanne Parsons
Bio-Rad Laboratories 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-30
Decision Date2014-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661005759 K134013 000
00847661005742 K134013 000
00847661005735 K134013 000
00847661005728 K134013 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.