Cleared Traditional

K850412 - GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
(FDA 510(k) Clearance)

K850412 · Warner-Lambert Co. · Hematology

May 1985

Decision

93d

Days

Class 2

Risk

K850412 is an FDA 510(k) clearance for the GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on May 8, 1985, 93 days after receiving the submission on February 4, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number	K850412 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1985
Decision Date	May 08, 1985
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—