Cleared Traditional

SYPHILIS IGM HUMAN SERUM CONTROLS

K961317 · Pyramid Biological Corp. · Microbiology
Jun 1996
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K961317 is an FDA 510(k) clearance for the SYPHILIS IGM HUMAN SERUM CONTROLS, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on June 24, 1996, 80 days after receiving the submission on April 5, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K961317 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1996
Decision Date June 24, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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