Cleared Traditional

X-ACT UREA/TDA

K883995 · Pro-Lab, Inc. · Microbiology
Oct 1988
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K883995 is an FDA 510(k) clearance for the X-ACT UREA/TDA, a Culture Media, Multiple Biochemical Test (Class I — General Controls, product code JSE), submitted by Pro-Lab, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 12, 1988, 22 days after receiving the submission on September 20, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K883995 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1988
Decision Date October 12, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSE — Culture Media, Multiple Biochemical Test
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320