510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880641Substantially Equivalent

Sensititre Stability Plates

Sensititre, Ltd., Salem NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880641 is the FDA 510(k) clearance record for SENSITITRE STABILITY PLATES, a class II device, cleared for Sensititre , Ltd. on under FDA product code JWY (Manual Antimicrobial Susceptibility Test Systems). FDA records list 3 510(k) clearances for Sensititre , Ltd., from to . As of , FDA records show 9 recalls naming K880641.

Clearance record

Decision date
Received
(92 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 , Ltd. 8a Industrial Way #2, Salem NH
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