510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K912778Substantially Equivalent

Hp-Haemophilus/pneumococcus Mic Plate

Sensititre Microbiology A Div. of Radiometer, Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912778 is the FDA 510(k) clearance record for HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE, a class II device, cleared for Sensititre Microbiology A Div. of Radiometer on under FDA product code JWY (Manual Antimicrobial Susceptibility Test Systems). FDA records list 3 510(k) clearances for Sensititre Microbiology A Div. of Radiometer, from to . As of , FDA records show no recalls naming K912778.

Clearance record

Decision date
Received
(239 days to decision)
Product code
JWY Manual Antimicrobial Susceptibility Test Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Sensititre Microbiology A Div. of Radiometer 811 Sharon Dr., Westlake OH
510(k) summary
Statement
Third party review
No

Clearances, product code JWY

Trailing 12 months
2 clearances under product code JWY in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260