CIBA CORNING ACS HCG IMMUNOASSAY

Visual, Pregnancy Hcg, Prescription Use

CIBA CORNING DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Hcg Immunoassay.

Pre-market Notification Details

Device IDK925277
510k NumberK925277
Device Name:CIBA CORNING ACS HCG IMMUNOASSAY
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
ContactWilliam J Pignato
CorrespondentWilliam J Pignato
CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-20
Decision Date1993-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414505183 K925277 000
00630414505176 K925277 000
00630414505152 K925277 000
00630414504742 K925277 000
00630414197418 K925277 000
00630414197401 K925277 000
00630414190969 K925277 000

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