Cleared Traditional

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE

K883776 · Btc Corp. · Microbiology
Feb 1989
Decision
150d
Days
Class 1
Risk

About This 510(k) Submission

K883776 is an FDA 510(k) clearance for the BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE, a Antisera, Fluorescent, Chlamydia Spp. (Class I — General Controls, product code LKI), submitted by Btc Corp. (Suisun, US). The FDA issued a Cleared decision on February 3, 1989, 150 days after receiving the submission on September 6, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K883776 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1988
Decision Date February 03, 1989
Days to Decision 150 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LKI — Antisera, Fluorescent, Chlamydia Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120