510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844322Substantially Equivalent

Sgot Reagent Set

Livonia Diagnostics, Inc., Livonia MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844322 is the FDA 510(k) clearance record for SGOT REAGENT SET, a class II device, cleared for Livonia Diagnostics, Inc. on under FDA product code CIQ (Diazo, Ast/Sgot). FDA records list 16 510(k) clearances for Livonia Diagnostics, Inc., from to . As of , FDA records show no recalls naming K844322.

Clearance record

Decision date
Received
(20 days to decision)
Product code
CIQ Diazo, Ast/Sgot
Regulation
21 CFR 862.1100
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Livonia Diagnostics, Inc. 33041 W. Eight Mile Rd., Livonia MI
Third party review
No

Clearances, product code CIQ

Trailing 12 months

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

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