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510(k) K802276

Device
FTA-ABS BIOPAK
Applicant
BIOWARE PRODUCTS
510(k) number
K802276
Product code
JWL  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-23
Date received
1980-09-18
Regulation
866.3830
Classification name
Antigen, Treponema Pallidum For Fta-abs Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
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 JWL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831296POLYCHACO FIA-ABS TEST FOR SYPHILISParasitic Disease Consultants1983-07-26
K801959FTA-ABS TESTImmuno-Diagnostic Products, Inc.1980-10-23
K801928LAB-TEK FTA-ABS KITMiles Laboratories, Inc.1980-08-20

Legacy Summary#

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FDA Review#

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