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510(k) K921637

Device
ESP BLOOD CULTURE SYSTEM
Applicant
DIFCO LABORATORIES, INC.
510(k) number
K921637
Product code
MDB  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-14
Date received
1992-04-06
Regulation
866.2560
Classification name
System, Blood Culturing
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JERRY W SMITH
Address
1180 Ellsworth Rd. Ann Arbor MI US 48104 48104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MDB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company2023-03-24
K222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company2023-03-24
K190405BACT/ALERT MP Reagent SystembioMerieux, Inc.2019-05-15
K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.2019-02-11
K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company2018-03-16
K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc.2017-03-28
K161810BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson2017-02-09
K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson2016-08-08
K151866BD BACTEC Peds Plus/F Culture Vials (plastic)Becton, Dickinson and Company2016-02-25
K141810BD BACTEC PLUS ANAEROBIC/F (PLASTIC)Becton, Dickinson and Company2014-12-10
K123903BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)Becton, Dickinson & CO2013-05-13
K121446BACT/ALERT PF PLUS CULTURE BOTTLEbioMerieux, Inc.2013-01-25
K121455BACT/ALERT FN PLUS CULTURE BOTTLEbioMerieux, Inc.2013-01-25
K121461BACT/ALERT FA PLUS CULTURE BOTTLEbioMerieux, Inc.2013-01-22
K120994BD BACTEC Plus PRIME Aerobic/F Culture VialsBecton, Dickinson and Company2012-08-07

Legacy Summary#

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FDA Review#

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