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510(k) K875180

Device
V-TREND RPRL CARD TEST
Applicant
TEXAS IMMUNOLOGY, INC.
510(k) number
K875180
Product code
GMP  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-04
Date received
1987-12-17
Regulation
866.3820
Classification name
Antisera, Control For Nontreponemal Tests
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHARLES W GILL
Address
5400 Spur 248 Tyler TX US 75707 75707

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980638ADI SYPHILIS RPR LIQUID CONTROLSAmpcor Diagnostics, Inc.1998-07-06
K961998QUALITROL SYPHSERO CONTROL SETConsolidated Technologies, Inc.1996-08-08
K955143RPR LIQUID CONTROLSRemel, L.P.1996-07-30
K885298VISUWELL REAGIN TEST 960 TEST KITAllelix Diagnostics, Inc.1989-03-15
K851504VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010Ncs Diagnostics, Inc.1985-08-19
K843741RPR TEST REDITESTBiokit USA, Inc.1984-10-25
K812425BECKMAN R.PR CONTROL SERUM SETBeckman Instruments, Inc.1981-09-23
K810119CONTROL SERUMS FOR NONTREPONEMAL TESTHillside Acres, Inc.1981-02-09

Legacy Summary#

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FDA Review#

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