FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHEUMELISA II SCL-70 ANTIBODY TEST KIT
K Number: K930130
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
10
Review Days
70
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
- RHEUMELISA II SCL-70 ANTIBODY TEST KIT
- K Number
- K930130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biowhittaker Molecular Applications, Inc.
- Date Received
- January 12, 1993
- Decision Date
- March 23, 1993
- 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 Biowhittaker Molecular Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943843 | VARICELISA, MODIFICATION | Mar 14, 1996 | Substantially Equivalent |
| K942361 | WHITSOFT | Apr 4, 1995 | Substantially Equivalent |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | Apr 4, 1995 | Substantially Equivalent |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | Apr 3, 1995 | Substantially Equivalent |
| K925209 | MUMPS STAT | Oct 14, 1994 | Substantially Equivalent |
| K935618 | SPECIMEN TRANSPORT MEDIUM | Apr 21, 1994 | Substantially Equivalent |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | Aug 23, 1993 | Substantially Equivalent |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | Mar 26, 1993 | Substantially Equivalent |
| K920753 | RF STAT IGM TEST KIT | Mar 30, 1992 | Substantially Equivalent |