Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack— 510(k) K143651

Clearance details

Applicant

Focus Diagnostics, Inc.

Product code

Code PGX

Device class

Class 2

Regulation

21 CFR 866.2680

Advisory panel

Microbiology

Date received

2014-12-23

Decision date

2015-03-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cypress, CA, US

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• Z-1274-2016 — Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455Class I·Terminated·Focus Diagnostics Inc·20160210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143651.