JWYClass II

Manual Antimicrobial Susceptibility Test Systems

21 CFR 866.1640 / Microbiology

JWY is the FDA product code for Manual Antimicrobial Susceptibility Test Systems, a class II device type, regulated under 21 CFR 866.1640. As of 2026-09-10, FDA records hold 441 510(k) clearances under this code, the most recent dated 2026-04-21, and 78 recalls.

Classification record

Product code: JWY
Device name: Manual Antimicrobial Susceptibility Test Systems
Regulation: 21 CFR 866.1640
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 441
Ingested recalls: 78

Clearances, product code JWY

By decision year

441 clearances under product code JWY with a decision year between 1981 and 2026, 1988 the highest year at 31.

Show the numbers

510(k) clearances under FDA product code JWY by decision year
Year	Clearances
1981	1
1984	1
1985	8
1986	17
1987	8
1988	31
1989	6
1990	9
1991	26
1992	8
1993	13
1994	7
1995	25
1996	14
1997	15
1998	24
1999	19
2000	14
2001	13
2002	28
2003	9
2004	10
2005	4
2006	12
2008	6
2009	2
2010	4
2011	4
2012	1
2014	6
2015	9
2016	4
2017	14
2018	12
2019	18
2020	5
2021	5
2023	7
2024	6
2025	14
2026	2

Applicants with the most clearances

Product code JWY

Applicants holding the most 510(k) clearances under product code JWY
Applicant	Clearances
Ab Biodisk	61
Trek Diagnostic Systems, Ltd.	51
Thermo Fisher Scientific Oy	47
Pasco Laboratories, Inc.	39
Liofilchem S.r.l.	35
BD Becton Dickinson Vacutainer Systems Preanalytic	32
Dade Microscan, Inc.	26
Alamar Biosciences Laboratory, Inc.	22
bioMerieux, Inc.	18
Baxter Diagnostics, Inc.	12

Companies listing this code with FDA

Companies whose registered establishments list this code