Osom Influenza A&B Test , Model PN190
FDA 510(k) K092633 · Genzyme Corporation
510(k) numberK092633
Submission
- Device name
- Osom Influenza A&B Test , Model PN190
- Applicant
- Genzyme Corporation
Cambridge, MA, US - Received
- August 27, 2009
- Decision date
- September 25, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSZ – Devices Detecting Influenza A, B, And C Virus Antigens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3328
- Specialty
- Microbiology
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.
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| K182001 | Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 12/17/2018SE |
| K182157 | BioSign Flu A+BPSZ · Special | Princeton BioMeditech Corp. | 09/18/2018SE |
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Questions and answers
When was Osom Influenza A&B Test , Model PN190 cleared by the FDA?
Osom Influenza A&B Test , Model PN190 (K092633) received a 510(k) decision of Substantially Equivalent on September 25, 2009, 29 days after the submission was received.
What is the product code of K092633?
The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.