Cleared Traditional

SYPHILIS IGG HUMAN SERUM CONTROLS

K960493 · Pyramid Biological Corp. · Microbiology
Jun 1996
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K960493 is an FDA 510(k) clearance for the SYPHILIS IGG 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 17, 1996, 137 days after receiving the submission on February 1, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K960493 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1996
Decision Date June 17, 1996
Days to Decision 137 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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