FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUALITROL ANA CONTROL SERUM SET
K Number: K961815
·
Decision Sep 27, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
49
Applicant Total
20
Review Days
140
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
- QUALITROL ANA CONTROL SERUM SET
- K Number
- K961815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Consolidated Technologies, Inc.
- Date Received
- May 10, 1996
- Decision Date
- September 27, 1996
- Product Code
- LKJ
- 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 |
|---|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKJ), ordered by most recent decision date.
EliA Ro52, EliA Ro60
FDA 510(k)
FDA Class 2
·Immunology
ANA-SCREEN WITH MDSS
FDA 510(k)
FDA Class 2
·Immunology
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
AESKULISA ANA HEP-2, REF 30-7115US
FDA 510(k)
FDA Class 2
·Immunology
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
FDA 510(k)
FDA Class 2
·Immunology
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Consolidated Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000116 | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 | Feb 15, 2000 | Substantially Equivalent |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Sep 3, 1999 | Substantially Equivalent |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Sep 3, 1999 | Substantially Equivalent |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Jul 14, 1999 | Substantially Equivalent |
| K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 | Apr 21, 1998 | Substantially Equivalent |
| K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE | Jan 22, 1998 | Substantially Equivalent |
| K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS | Sep 25, 1997 | Substantially Equivalent |
| K972146 | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS | Jul 8, 1997 | Substantially Equivalent |
| K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 | Jun 18, 1997 | Substantially Equivalent |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Sep 24, 1996 | Substantially Equivalent |