Medical Device Manufacturer · CA , Canada L4v 1p1

Allelix Diagnostics, Inc.

2 submissions · 2 cleared · Since 1988

Total

Cleared

Denied

Allelix Diagnostics, Inc. — FDA 510(k) Submissions

Allelix Diagnostics, Inc. has submitted 2 FDA 510(k) premarket notifications since 1988, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antisera, All Groups, Streptococcus Spp., Antisera, Control For Nontreponemal Tests . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

VISUWELL REAGIN TEST 960 TEST KIT

K885298 · GMP Antisera, Control For... · Microbiology

Mar 1989 78d

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT

K880665 · GTZ Antisera, All Groups,... · Microbiology

Mar 1988 12d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Allelix Diagnostics, Inc.

Allelix Diagnostics, Inc. — FDA 510(k) Submissions

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