510(k) K990916
- Device
- INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
- Applicant
- STELLAR BIO SYSTEMS, INC.
- 510(k) number
- K990916
- Product code
- KTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-04-21
- Date received
- 1999-03-18
- Regulation
- 866.5100
- Classification name
- Anti-dna Indirect Immunofluorescent Solid Phase
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN BREWER
- Address
- 9075 Guilford Rd. Columbia MD US 21046 21046
FDA Registration Numbers#
- 2918768
- 2026994
- 3007361513
- 3003268355
- 2242436
- 3026753391
- 3007118747
- 2915274
Source Documents#
Other 510(k) Records For Product Code KTL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific | 2023-08-31 |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | Immuno Concepts, N.A. , Ltd. | 2023-05-26 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | 2020-12-11 |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Rhigene, Inc. | 2002-04-11 |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Immuno Concepts, Inc. | 2001-11-29 |
| K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | The Binding Site, Ltd. | 1993-08-10 |
| K905386 | DISTAT ANTI-DSDNA KIT | Shield Diagnostics, Ltd. | 1990-12-13 |
| K864275 | ANTI-NDNA ANTIBODY TEST KIT | Cappel Diagnostics, Inc. | 1986-12-15 |
| K861978 | AUTOFLUOR V | Technia Diagnostics , Ltd. | 1986-06-10 |
| K842707 | ADP NDNA IFA TEST | Apple Diagnostic Products | 1984-08-21 |
| K834349 | ANTI-NATIVE DNA ANTIBODY | Sigma Chemical Co. | 1984-04-19 |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Intl. Diagnostic Technology | 1984-01-20 |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Intl. Diagnostic Technology | 1984-01-04 |
Legacy Summary#
summary
FDA Review#
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