Cleared Traditional

K833369 - EARLY DETECTOR
(FDA 510(k) Clearance)

K833369 · Warner-Lambert Co. · Hematology

Aug 1984

Decision

310d

Days

Class 2

Risk

K833369 is an FDA 510(k) clearance for the EARLY DETECTOR, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Warner-Lambert Co. (Walker, US). The FDA issued a Cleared decision on August 2, 1984, 310 days after receiving the submission on September 27, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K833369 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 1983
Decision Date	August 02, 1984
Days to Decision	310 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—