Cleared Traditional

K861634 - THE WELLCOME ROTAVIRUS LATEX TEST ZL40 (FDA 510(k) Clearance)

K861634 · Wellcome Diagnostics · Microbiology device

Oct 1986

Decision

183d

Days

Class 1

Risk

K861634 is an FDA 510(k) clearance for the THE WELLCOME ROTAVIRUS LATEX TEST ZL40. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I - General Controls, product code LIQ).

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on October 29, 1986, 183 days after receiving the submission on April 29, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number	K861634 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 29, 1986
Decision Date	October 29, 1986
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—