FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
K Number: K093784
·
Decision Jul 16, 2010
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
135
Review Days
219
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Basic Information
- Device Name
- ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
- K Number
- K093784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zeus Scientific, Inc.
- Date Received
- December 9, 2009
- Decision Date
- July 16, 2010
- Product Code
- OPM
- 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 |
|---|---|---|---|
| OPM | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 | FDA class 2 | Microbiology |
Other Clearances by Zeus Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Apr 29, 2022 | Substantially Equivalent |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Jul 29, 2019 | Substantially Equivalent |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Jul 29, 2019 | Substantially Equivalent |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Jul 29, 2019 | Substantially Equivalent |
| K113397 | ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM | Jul 26, 2012 | Substantially Equivalent |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | Dec 12, 2011 | Substantially Equivalent |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | May 20, 2011 | Substantially Equivalent |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | Apr 26, 2011 | Substantially Equivalent |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | Feb 10, 2011 | Substantially Equivalent |
| K100728 | ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM | Jul 6, 2010 | Substantially Equivalent |