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510(k) K801949

Device
BCM-302 COLLIMATING CONE & COMPENSATIN
Applicant
B C MEDICAL LTD.
510(k) number
K801949
Product code
JZW  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-03
Date received
1980-08-15
Regulation
866.4540
Classification name
Nephelometer
Medical specialty
Immunology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001647BN PROSPEC SYSTEMDade Behring, Inc.2000-09-26
K761234BEHRING LASER NEPHELOMETERBehring Diagnostics, Inc.1990-06-07
K892223BEHRING NEPHELOMETER 100Behring Diagnostics, Inc.1989-05-04
K873401TURBOXUnipath , Ltd.1987-09-23
K873407RRT SYSTEM LASER REFLECTOMETER ANALYZERIncstar Corp.1987-09-23
K801391DISC 120 TRANSPORTERTravenol Laboratories, S.A.1980-07-14
K792014LANCER L-INA BUFFER, POLYMER, WASH SOLUSherwood Medical Industries1979-11-13
K781006IMMUNOCHEMISTRY SYS. MANUAL MODEBeckman Instruments, Inc.1978-08-31
K761235LASER STANDARD SERUMBehring Diagnostics, Inc.1976-12-30
K761236ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.Behring Diagnostics, Inc.1976-12-30

Legacy Summary#

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FDA Review#

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