Code Qas 103 Anti-Dna Controls
FDA 510(k) K791354 · Amersham Corp.
510(k) numberK791354
Submission
- Device name
- Code Qas 103 Anti-Dna Controls
- Applicant
- Amersham Corp.
Mchenry, IL, US - Received
- July 18, 1979
- Decision date
- September 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTL – Anti-Dna Indirect Immunofluorescent Solid Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code KTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | Zeus Scientific | 08/31/2023SE |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemKTL · Traditional | Immuno Concepts, N.A. , Ltd. | 05/26/2023SE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | Inova Diagnostics, Inc. | 12/11/2020SE |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL · Traditional | Euroimmun Us, Inc. | 04/20/2018SE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | Euroimmun Us, Inc. | 04/20/2018SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | Rhigene, Inc. | 04/11/2002SE |
| K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040GKTL · Traditional | Immuno Concepts, Inc. | 11/29/2001SE |
| K990916 | Indirect Fluorescence Assay for Anti-Native DNA Igg AntibodyKTL · Traditional | Stellar Bio Systems, Inc. | 04/21/1999SE |
| K930987 | Crithidia Lucilliae DS DNA Kit (Diagnostic Use)KTL · Traditional | The Binding Site, Ltd. | 08/10/1993SE |
| K905386 | Distat Anti-Dsdna KitKTL · Traditional | Shield Diagnostics, Ltd. | 12/13/1990SE |
More from Shield Diagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Code Qas 103 Anti-Dna Controls cleared by the FDA?
Code Qas 103 Anti-Dna Controls (K791354) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 61 days after the submission was received.
What is the product code of K791354?
The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.