510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944319Substantially Equivalent

Biomic Microbiology Data Management System

Giles Scientific Inc, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944319 is the FDA 510(k) clearance record for BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM, a class I device, cleared for Giles Scientific, Inc. on under FDA product code KZK (Reader, Zone, Automated). FDA records list 4 510(k) clearances for Giles Scientific, Inc., from to . As of , FDA records show no recalls naming K944319.

Clearance record

Decision date
Received
(104 days to decision)
Product code
KZK Reader, Zone, Automated
Regulation
21 CFR 866.2850
Device class
Class I
Review panel
Microbiology
Applicant
Giles Scientific, Inc. 250 Mercer St., New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code KZK

Trailing 12 months

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

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