Atlas FDA

BACT/ALERT (TM)

FDA 510(k) clearance K903505 · decided 1991-03-12

Clearance details

K-number
K903505
Device name
BACT/ALERT (TM)
Applicant
Organon Teknika Corp.
Decision
Substantially Equivalent
Date received
1990-08-03
Decision date
1991-03-12
Days to decision
221 days
Clearance type
Traditional
Product code
MDB
Device class
1
Regulation number
866.2560
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Durham, NC, 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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BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873)Becton, Dickinson and Company2018-03-16
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816)bioMerieux, Inc.2017-03-28
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810)Becton Dickinson2017-02-09
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306)Becton Dickinson2016-08-08
BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866)Becton, Dickinson and Company2016-02-25
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810)Becton, Dickinson and Company2014-12-10
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903)Becton, Dickinson & CO2013-05-13

Recalls involving this device

RecordFirmDate
BacT/ALERT Classic System Software, Blood Culturing System recall (Z-0773-2007)bioMerieux, Inc.2007-05-03
BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerie recall (Z-0644-2007)bioMerieux, Inc.2007-03-22
Bac T/ALERT 3D Control Module recall (Z-0612-05)BIOMERIEUX, INC.2005-09-07
Bac T/ALERT 3D Combination Module recall (Z-0613-05)BIOMERIEUX, INC.2005-09-07
Bac T/ALERT 3D 60 recall (Z-0614-05)BIOMERIEUX, INC.2005-09-07
BacT/ALERT(BTA) Classic instruments. recall (Z-0456-05)bioMerieux2005-02-01

PMA approvals by this applicant

RecordFirmDate
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001)Organon Teknika Corp.1990-03-21
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001)Organon Teknika Corp.1990-03-21
9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001)Organon Teknika Corp.1990-03-21
AUTOBAC MIC TEST SYSTEM (N50524/S033)Organon Teknika Corp.1990-01-22
AUTOBAC MIC TEST SYSTEM (N50524/S035)Organon Teknika Corp.1989-12-07
AUTOBAC MIC TEST SYSTEM (N50524/S032)Organon Teknika Corp.1989-06-13
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018)Organon Teknika Corp.1989-02-06
AUTOBAC MIC TEST SYSTEM (N50524/S031)Organon Teknika Corp.1988-12-28