510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JWLClass II

Antigen, Treponema Pallidum For Fta-Abs Test

21 CFR 866.3830 / Microbiology
FDA source (opens on fda.gov)

JWL is the FDA product code for Antigen, Treponema Pallidum For Fta-Abs Test, a class II device type, regulated under 21 CFR 866.3830. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JWL
Device name
Antigen, Treponema Pallidum For Fta-Abs Test
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code JWL

By decision year
4 clearances under product code JWL with a decision year between 1980 and 1983, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JWL by decision year
YearClearances
19803
19831

Applicants with the most clearances

Product code JWL
Applicants holding the most 510(k) clearances under product code JWL
ApplicantClearances
Bioware Products1
Immuno-Diagnostic Products, Inc.1
Miles Laboratories, Inc.1
Parasitic Disease Consultants1

Companies listing this code with FDA

Companies whose registered establishments list this code