ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT

Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Add'l Uses For The Kodak Surecell Chlamydia Kit.

Pre-market Notification Details

Device IDK900402
510k NumberK900402
Device Name:ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactNorman H Geil
CorrespondentNorman H Geil
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeLJC  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-29
Decision Date1990-03-08

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