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510(k) K852506

Device
BIOGLAS MICROCARRIER BEAD
Applicant
SOLOHILL ENGINEERING, INC.
510(k) number
K852506
Product code
KJB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-12
Date received
1985-06-12
Regulation
864.2240
Classification name
Apparatus, Roller
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM J HILLEGAS
Address
323 E. William, Suite 44 Ann Arbor MI US 48104 48104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881466CELL-CULTURE SHAKERCryodyne Technologies, Inc.1988-04-18
K872076CORNING DISPOSABLE ROLLER BOTTLESCorning Medical & Scientific1987-06-15

Legacy Summary#

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FDA Review#

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