FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DNA STAT TEST KIT
K Number: K843904
·
Decision Nov 1, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
30
Review Days
29
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
- DNA STAT TEST KIT
- K Number
- K843904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Whittaker Bioproducts, Inc.
- Date Received
- October 3, 1984
- Decision Date
- November 1, 1984
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJM), ordered by most recent decision date.
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced Centromere Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
ELIA SCL-70S IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH CENTROMERE
FDA 510(k)
FDA Class 2
·Immunology
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ANA SCREEN ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Whittaker Bioproducts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Jul 30, 1992 | Substantially Equivalent |
| K913212 | 3M IGE SINGLE POINT FAST TEST | Nov 22, 1991 | Substantially Equivalent |
| K904652 | LYME STAT M TEST KIT | Oct 21, 1991 | Substantially Equivalent |
| K904893 | FIAX LYME M TEST KIT | Oct 16, 1991 | Substantially Equivalent |
| K911473 | EBNA STAT TEST KIT | Sep 25, 1991 | Substantially Equivalent |
| K905468 | PYLORI-G FIAX TEST KIT | May 7, 1991 | Substantially Equivalent |
| K904738 | PYLORI STAT TEST KIT | May 7, 1991 | Substantially Equivalent |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Jun 27, 1990 | Substantially Equivalent |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Jan 16, 1990 | Substantially Equivalent |
| K894932 | FIAX EB VCA-M TEST KIT | Oct 16, 1989 | Substantially Equivalent |