JWL · Class II · 21 CFR 866.3830

FDA Product Code JWL: Antigen, Treponema Pallidum For Fta-abs Test

Leading manufacturers include Miles Laboratories, Inc., Immuno-Diagnostic Products, Inc. and Bioware Products.

4
Total
4
Cleared
51d
Avg days
1980
Since

FDA 510(k) Cleared Antigen, Treponema Pallidum For Fta-abs Test Devices (Product Code JWL)

4 devices
1–4 of 4
Cleared Jul 26, 1983
POLYCHACO FIA-ABS TEST FOR SYPHILIS
K831296
Parasitic Disease Consultants
Immunology · 97d
Cleared Oct 23, 1980
FTA-ABS TEST
K801959
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
FTA-ABS BIOPAK
K802276
Bioware Products
Microbiology · 35d
Cleared Aug 20, 1980
LAB-TEK FTA-ABS KIT
K801928
Miles Laboratories, Inc.
Microbiology · 8d

About Product Code JWL - Regulatory Context