510(k) K061508

OSOM INFLUENZA A&B TEST by Genzyme Corp. — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 12, 2006
Date Received: June 1, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: Class II
Regulation Number: 866.3328
Review Panel: MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other clearances by Genzyme Corp.

K051244 — GENZYME OSOM INFLUENZA A & B TEST (February 21, 2006)
K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (June 25, 2004)
K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (June 4, 2004)
K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST (January 16, 2003)
K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTR (July 25, 2002)
K021019 — COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (June 18, 2002)
K012532 — SEPRAGEL SINUS (October 30, 2001)
K011843 — GENZYME DIRECT-AMYLASE TEST REAGENT (August 10, 2001)
K000239 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (March 21, 2000)

Other clearances for product code PSZ

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K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
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K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
K182157 — BioSign Flu A+B (September 18, 2018)
K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)