Atlas FDA

BD DIRECTIGEN FLU A+B

FDA 510(k) clearance K001364 · decided 2000-06-28

Clearance details

K-number
K001364
Device name
BD DIRECTIGEN FLU A+B
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
2000-05-01
Decision date
2000-06-28
Days to decision
58 days
Clearance type
Traditional
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sparks, MD, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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Nano-Check Influenza A+B Test (K252283)Nano-Ditech Corporation2026-01-15
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Acucy® Influenza A&B Test with the Acucy® 2 System (K241188)SEKISUI Diagnostics, LLC2025-04-18
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (K232434)Bd2023-12-05
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)Bd2023-01-27
Osom Ultra Plus Flu A&B Test Kit (K192719)SEKISUI Diagnostics, LLC2020-04-03
CareStart Flu A&B Plus (K191514)Access Bio, Inc.2020-02-18
Acucy Influenza A&B Test with the Acucy System (K182001)SEKISUI Diagnostics, LLC2018-12-17
BioSign Flu A+B (K182157)Princeton BioMeditech Corp.2018-09-18
Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853)Alere Scarborough, Inc.2018-08-08
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438)Bd2018-03-20
QuickVue Influenza A+B (K180288)Quidel Corporation2018-02-13

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05