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510(k) K882637

Device
ACCU-CULSHURE TM
Applicant
ACCU-MED CORP.
510(k) number
K882637
Product code
JTX  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-06
Date received
1988-06-27
Regulation
866.2900
Classification name
Transport Systems, Anaerobic
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOANN HANCHROW
Address
270 Marble Ave. Pleasantville NY US 10570 10570

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901645ANAEROBIC ACCU-CULSHURE(TM)Medical Laboratory Automation Systems, Inc.1990-07-16
K897151ACUSON V328 AND C5432 TRANSDUCERSAcuson Corp.1990-07-03
K791724BIO-BAG ENVIRONMENTAL CHAMBER (A & B)Marion Laboratories, Inc.1979-10-17
K781376STANDARDIZE TGCL & TGCHAmerican Monitor Corp.1978-09-14
K780159ANASWABScott Laboratories, Inc.1978-02-13
K761241PRE-DUCED SURGI-SWAB & TRANSPORTER TUBEGibco Laboratories Life Technologies, Inc.1976-12-30
K760063SPECIMEN COLLECTOR, ANAEROBICBd Becton Dickinson Vacutainer Systems Preanalytic1976-08-03

Legacy Summary#

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FDA Review#

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