510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813191Substantially Equivalent

Shigella Sera-Chek

Lab Ability, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813191 is the FDA 510(k) clearance record for SHIGELLA SERA-CHEK, a class II device, cleared for Lab Ability, Inc. on under FDA product code LIA (Antigens, All Groups, Shigella Spp.). FDA records list 5 510(k) clearances for Lab Ability, Inc., from to . As of , FDA records show no recalls naming K813191.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LIA Antigens, All Groups, Shigella Spp.
Regulation
21 CFR 866.3660
Device class
Class II
Review panel
Microbiology
Applicant
Lab Ability, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LIA

Trailing 12 months

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

FDA records show no clearances under product code LIA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIA, 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