Cleared Traditional

K802276 - FTA-ABS BIOPAK
(FDA 510(k) Clearance)

K802276 · Bioware Products · Microbiology
Oct 1980
Decision
35d
Days
Class 2
Risk

K802276 is an FDA 510(k) clearance for the FTA-ABS BIOPAK, a Antigen, Treponema Pallidum For Fta-abs Test (Class II — Special Controls, product code JWL), submitted by Bioware Products (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 35 days after receiving the submission on September 18, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K802276 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1980
Decision Date October 23, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JWL — Antigen, Treponema Pallidum For Fta-abs Test
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830