The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Ektachem Clinical Chemistry Slide For Acetaminophen.
Device ID | K954933 |
510k Number | K954933 |
Device Name: | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN |
Classification | Colorimetry, Acetaminophen |
Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
Contact | Yvonne E Middlefell |
Correspondent | Yvonne E Middlefell JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
Product Code | LDP |
CFR Regulation Number | 862.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-27 |
Decision Date | 1995-12-18 |