The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Early Detector.
Device ID | K833369 |
510k Number | K833369 |
Device Name: | EARLY DETECTOR |
Classification | Reagent, Occult Blood |
Applicant | WARNER-LAMBERT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KHE |
CFR Regulation Number | 864.6550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-27 |
Decision Date | 1984-08-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EARLY DETECTOR 76714668 4838701 Live/Registered |
VCM PRODUCTS, LLC 2013-08-01 |
EARLY DETECTOR 73424816 1302154 Dead/Cancelled |
Warner-Lambert Company 1983-05-06 |