FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZORBA(TM) IGG REMOVAL REAGENT
K Number: K924197
·
Decision Dec 15, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
135
Review Days
117
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ZORBA(TM) IGG REMOVAL REAGENT
- K Number
- K924197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- August 20, 1992
- Decision Date
- December 15, 1992
- Product Code
- DEW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEW), ordered by most recent decision date.
TINA-QUANT IGG GEN.2
FDA 510(k)
FDA Class 2
·Immunology
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
FDA 510(k)
FDA Class 2
·Immunology
SPIFE IFE CALIBRATOR AND CONTROL KIT
FDA 510(k)
FDA Class 2
·Immunology
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
FDA 510(k)
FDA Class 2
·Immunology
K-ASSAY IGG
FDA 510(k)
FDA Class 2
·Immunology
IGG
FDA 510(k)
FDA Class 2
·Immunology
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 |
| K093784 | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM | Jul 16, 2010 | Substantially Equivalent |