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510(k) K971591

Device
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
Applicant
DAVID C. BISHOP, PH.D.
510(k) number
K971591
Product code
LSQ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-13
Date received
1997-05-01
Regulation
866.3500
Classification name
Reagent, Rickettsia Serological
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID C BISHOP
Address
605 Dilworth Rd. Dowingtown PA US 19335 19335

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LSQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920569INDXTM DIP-S-TICKSTMIntercare Diagnostics, Inc.1993-02-09
K901597INDX DIP S TICKSIntercare Diagnostics, Inc.1990-12-21
K872129LATEX R. CONORIIHealth Research, Inc.1987-08-19

Legacy Summary#

summary

FDA Review#

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