BIOCHECK IGE ELISA, MODEL BC-1035

Ige, Antigen, Antiserum, Control

BIOCHECK, INC.

The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Ige Elisa, Model Bc-1035.

Pre-market Notification Details

Device IDK992528
510k NumberK992528
Device Name:BIOCHECK IGE ELISA, MODEL BC-1035
ClassificationIge, Antigen, Antiserum, Control
Applicant BIOCHECK, INC. 9418 LASAINE AVE. Northridge,  CA  91325
ContactRobin J Hellen
CorrespondentRobin J Hellen
BIOCHECK, INC. 9418 LASAINE AVE. Northridge,  CA  91325
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-28
Decision Date1999-09-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727013330 K992528 000
B24225IGEHUE010 K992528 000
00850392007350 K992528 000
00840239017888 K992528 000
04048474017885 K992528 000

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