510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885298Substantially Equivalent

Visuwell Reagin Test 960 Test Kit

Allelix Diagnostics, Inc., Canada L4v 1p1, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885298 is the FDA 510(k) clearance record for VISUWELL REAGIN TEST 960 TEST KIT, a class II device, cleared for Allelix Diagnostics, Inc. on under FDA product code GMP (Antisera, Control For Nontreponemal Tests). FDA records list 2 510(k) clearances for Allelix Diagnostics, Inc., from to . As of , FDA records show no recalls naming K885298.

Clearance record

Decision date
Received
(78 days to decision)
Product code
GMP Antisera, Control For Nontreponemal Tests
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Allelix Diagnostics, Inc. 6850 Goreway Dr., Canada L4v 1p1, CA
Third party review
No

Clearances, product code GMP

Trailing 12 months

FDA records hold no clearances under product code GMP in the trailing twelve months.

FDA records show no clearances under product code GMP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GMP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260