510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052485Substantially Equivalent

Sherlock Microbial Identification System for Biodef

Midi, Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052485 is the FDA 510(k) clearance record for SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF, a class II device, cleared for Midi, Inc. on under FDA product code NWZ (Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids). FDA's definition for product code NWZ reads: "Aid in the identification of Bacillus Anthracis". FDA records list 2 510(k) clearances for Midi, Inc., from to . As of , FDA records show no recalls naming K052485.

Clearance record

Decision date
Received
(130 days to decision)
Product code
NWZ Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Applicant
Midi, Inc. 125 Sandy Dr., Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWZ

Trailing 12 months

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

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