FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERATEST ENA(RNP/SM) DETERMINATION
K Number: K844743
·
Decision Feb 4, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
177
Applicant Total
20
Review Days
61
Basic Information
- Device Name
- SERATEST ENA(RNP/SM) DETERMINATION
- K Number
- K844743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- SERAGEN DIAGNOSTICS, INC.
- Date Received
- December 5, 1984
- Decision Date
- February 4, 1985
- 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.
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
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by SERAGEN DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K872148 | VIVID CHLAMYDIA(TM) | Aug 19, 1987 | Substantially Equivalent |
| K851663 | QUICK-COUNT HEMATOLOGY CONTROLS | Jul 23, 1985 | Substantially Equivalent |
| K852260 | QUICK-CHEM CALIBRATION SET | Jul 22, 1985 | Substantially Equivalent |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | Jun 25, 1985 | Substantially Equivalent |
| K851521 | LD-1(IMMUNO) SEPARATION SET | May 10, 1985 | Substantially Equivalent |
| K850209 | QUICK-LYTE | Feb 27, 1985 | Substantially Equivalent |
| K842563 | SERATEST DNA DETERMINATION | Oct 25, 1984 | Substantially Equivalent |
| K841504 | QUICK-COUNT PLUS 2 | Jun 11, 1984 | Substantially Equivalent |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | Apr 13, 1984 | Substantially Equivalent |
| K840863 | SERATEST RF LATEX DETERMINATION | Apr 4, 1984 | Substantially Equivalent |