FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
K Number: K924843
·
Decision Dec 1, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
23
Review Days
64
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
- IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
- K Number
- K924843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- General Biometrics, Inc.
- Date Received
- September 28, 1992
- Decision Date
- December 1, 1992
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLL), ordered by most recent decision date.
Alegria Flash CTD Screen
FDA 510(k)
FDA Class 2
·Immunology
Alegria Flash ENA Screen
FDA 510(k)
FDA Class 2
·Immunology
Aptiva CTD Essential Reagent
FDA 510(k)
FDA Class 2
·Immunology
EliA SymphonyS Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash HMGCR Reagents
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by General Biometrics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST | Aug 20, 1992 | Substantially Equivalent |
| K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST | Aug 20, 1992 | Substantially Equivalent |
| K911627 | IMMUNODOT BORRELIA (LYME) TEST | Apr 8, 1992 | Substantially Equivalent |
| K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST | Dec 30, 1991 | Substantially Equivalent |
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST | Dec 20, 1991 | Substantially Equivalent |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | Dec 9, 1991 | Substantially Equivalent |
| K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |