Cleared Traditional

H.PYLORI CONTROLS

K964675 · Pyramid Biological Corp. · Microbiology
Jan 1997
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K964675 is an FDA 510(k) clearance for the H.PYLORI CONTROLS, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on January 27, 1997, 67 days after receiving the submission on November 21, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K964675 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1996
Decision Date January 27, 1997
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LYR — Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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