FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
K Number: K960091
·
Decision Mar 20, 1996
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
15
Review Days
69
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
- ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
- K Number
- K960091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Helix Diagnostics, Inc.
- Date Received
- January 11, 1996
- Decision Date
- March 20, 1996
- Product Code
- LRM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRM), ordered by most recent decision date.
IMMULISA DSDNA ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
VARELISA SSDNA ANTIBODIES, MODEL 14896
FDA 510(k)
FDA Class 2
·Immunology
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
MDI DS-DNA TEST
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Helix Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | Sep 11, 2000 | Substantially Equivalent |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | Apr 5, 2000 | Substantially Equivalent |
| K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | May 12, 1998 | Substantially Equivalent |
| K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | Dec 15, 1995 | Substantially Equivalent |
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | Dec 15, 1995 | Substantially Equivalent |
| K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | Aug 24, 1995 | Substantially Equivalent |
| K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | Jul 18, 1995 | Substantially Equivalent |
| K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | Jul 17, 1995 | Substantially Equivalent |
| K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | Apr 20, 1994 | Substantially Equivalent |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Apr 20, 1994 | Substantially Equivalent |