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510(k) K881538

Device
ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR
Applicant
ACUMEDIA MANUFACTURERS, INC.
510(k) number
K881538
Product code
JSA  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-18
Date received
1988-04-08
Regulation
866.2350
Classification name
Culture Media, Antibiotic Assay
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CUNNINGHAM, PHD
Address
3651 Clipper Mill Rd. Baltimore MD US 21211 21211

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881534ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGARAcumedia Manufacturers, Inc.1988-04-18
K881535ANTIBIOTIC MEDIUM #6Acumedia Manufacturers, Inc.1988-04-18
K881536ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGARAcumedia Manufacturers, Inc.1988-04-18
K881537ANTIBIOTIC MEDIUM #19Acumedia Manufacturers, Inc.1988-04-18
K832575ANTIBIOTIC ASSAY BROTHAcumedia Manufacturers, Inc.1983-09-12
K832576BASE AGARAcumedia Manufacturers, Inc.1983-09-12
K832577SEED AGARAcumedia Manufacturers, Inc.1983-09-12

Legacy Summary#

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FDA Review#

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