510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120563Substantially Equivalent

Keypath Mrsa/mssa Blood Culture Test-Bt

Microphage, Inc., Longmont CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120563 is the FDA 510(k) clearance record for KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT, a class I device, cleared for Microphage, Inc. on under FDA product code OUS (Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt). FDA's definition for product code OUS reads: "The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility...". FDA records list 2 510(k) clearances for Microphage, Inc., from to . As of , FDA records show no recalls naming K120563.

Clearance record

Decision date
Received
(35 days to decision)
Product code
OUS Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
Regulation
21 CFR 866.2050
Device class
Class I
Review panel
Microbiology
Applicant
Microphage, Inc. 2400 Trade Centre Ave., Longmont CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUS

Trailing 12 months

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

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