510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843725Substantially Equivalent

Biogram

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

K843725 is the FDA 510(k) clearance record for BIOGRAM, a class II device, cleared for Giles Scientific, Inc. on under FDA product code JTN (Susceptibility Test Discs, Antimicrobial). FDA records list 4 510(k) clearances for Giles Scientific, Inc., from to . As of , FDA records show no recalls naming K843725.

Clearance record

Decision date
Received
(239 days to decision)
Product code
JTN Susceptibility Test Discs, Antimicrobial
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Giles Scientific, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JTN

Trailing 12 months
6 clearances under product code JTN in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JTN, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20262
August 20261
September 20260
October 20260