510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020689Substantially Equivalent

Sherlock Mycobacteria Identification System

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

K020689 is the FDA 510(k) clearance record for SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM, a class I device, cleared for Midi, Inc. on under FDA product code NJO (System, Mycolic Acid Analysis, Mycobacterium Tuberculosis). FDA's definition for product code NJO reads: "A mycolic acids analysis system is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high...". FDA records list 2 510(k) clearances for Midi, Inc., from to . As of , FDA records show no recalls naming K020689.

Clearance record

Decision date
Received
(241 days to decision)
Product code
NJO System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
Regulation
21 CFR 866.3370
Device class
Class I
Review panel
Microbiology
Applicant
Midi, Inc. 125 Sandy Dr., Newark DE
510(k) summary
Statement
Third party review
No

Clearances, product code NJO

Trailing 12 months

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

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