510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191288Substantially Equivalent

Acuitas AMR Gene Panel

Opgen, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191288 is the FDA 510(k) clearance record for Acuitas AMR Gene Panel, a class II device, cleared for Opgen, Inc. on under FDA product code PMY (System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony). FDA's definition for product code PMY reads: "To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology". FDA records list one 510(k) clearance for Opgen, Inc. As of , FDA records show no recalls naming K191288.

Clearance record

Decision date
Received
(871 days to decision)
Product code
PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Opgen, Inc. 9717 Key W. Ave., Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMY

Trailing 12 months

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

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