510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K780048Substantially Equivalent

Aminoglycoside Test System

Nichols Institute Diagnostics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780048 is the FDA 510(k) clearance record for AMINOGLYCOSIDE TEST SYSTEM, a class II device, cleared for Nichols Institute Diagnostics on under FDA product code DID (Bacillus Subtilis Microbiology Assay, Tobramycin). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K780048.

Clearance record

Decision date
Received
(11 days to decision)
Product code
DID Bacillus Subtilis Microbiology Assay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Nichols Institute Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DID

Trailing 12 months

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

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