510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160032Unknown

Accelerate Pheno system, Accelerate Phenotest BC Kit

Accelerate Diagnotics, Tucson AZ / Direct, Unknown
FDA source (opens on fda.gov)

DEN160032 is the FDA 510(k) clearance record for Accelerate Pheno system, Accelerate Phenotest BC Kit, a class II device, cleared for Accelerate Diagnotics on under FDA product code PRH (Positive Blood Culture Identification And Ast Kit). FDA's definition for product code PRH reads: "Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets". FDA records list one 510(k) clearance for Accelerate Diagnotics. As of , FDA records show no recalls naming DEN160032.

Clearance record

Decision date
Received
(227 days to decision)
Product code
PRH Positive Blood Culture Identification And Ast Kit
Regulation
21 CFR 866.1650
Device class
Class II
Review panel
Microbiology
Applicant
Accelerate Diagnotics 3950 S. Country Club Rd. #470, Tucson AZ
Third party review
No

Clearances, product code PRH

Trailing 12 months

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

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