Cleared Traditional

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

K954515 · Pyramid Biological Corp. · Microbiology
Dec 1995
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K954515 is an FDA 510(k) clearance for the ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA, a Antisera, Cf, Rubella (Class II — Special Controls, product code GOM), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on December 20, 1995, 83 days after receiving the submission on September 28, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K954515 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1995
Decision Date December 20, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GOM — Antisera, Cf, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510