FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSOM INFLUENZA A&B TEST
K Number: K061508
·
Decision Jun 12, 2006
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
27
Review Days
11
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Basic Information
- Device Name
- OSOM INFLUENZA A&B TEST
- K Number
- K061508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Corp.
- Date Received
- June 1, 2006
- Decision Date
- June 12, 2006
- Product Code
- PSZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | FDA class 2 | Microbiology |
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Other Clearances by Genzyme Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K051244 | GENZYME OSOM INFLUENZA A & B TEST | Feb 21, 2006 | Substantially Equivalent |
| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Jun 25, 2004 | Substantially Equivalent |
| K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | Jun 4, 2004 | Substantially Equivalent |
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | Apr 2, 2004 | Substantially Equivalent |
| K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST | Jan 16, 2003 | Substantially Equivalent |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | Jul 25, 2002 | Substantially Equivalent |
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE | Jun 18, 2002 | Substantially Equivalent |
| K012532 | SEPRAGEL SINUS | Oct 30, 2001 | Substantially Equivalent |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | Aug 10, 2001 | Substantially Equivalent |
| K000239 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | Mar 21, 2000 | Substantially Equivalent |