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.
Device ID | K900402 |
510k Number | K900402 |
Device Name: | ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT |
Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Norman H Geil |
Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | LJC |
CFR Regulation Number | 866.3120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-29 |
Decision Date | 1990-03-08 |