510(k) K030681
- Device
- QUANTA PLEX ENA PROFILE 5
- Applicant
- Inova Diagnostics, Inc.
- 510(k) number
- K030681
- Product code
- LLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-24
- Date received
- 2003-03-05
- Regulation
- 866.5100
- Classification name
- Extractable Antinuclear Antibody, Antigen And Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- BRYS C MYERS
- Address
- 10180 Scripps Ranch Blvd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 3003825930
- 1421346
- 3039353646
- 3002800697
- 8043792
- 3003268355
- 3004973408
- 2090110
- 2245285
- 9680745
- 2915274
- 3007118747
- 1181055
- 1222302
- 1318354
- 3007361513
- 2026994
- 9610566
- 3012348571
- 2242436
- 3015376545
- 2029372
- 2918768
- 3003935253
- 3007208259
Source Documents#
510(k) summary PDF not indicated by FDA
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| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Phadia US, Inc. | 2008-01-15 |