FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K Number: K991096
·
Decision May 13, 1999
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
321
Review Days
42
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
- IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
- K Number
- K991096
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Products Corp.
- Date Received
- April 1, 1999
- Decision Date
- May 13, 1999
- Product Code
- JZO
- 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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZO), ordered by most recent decision date.
ADVIA Centaur Anti-Thyroid Peroxidase II
FDA 510(k)
FDA Class 2
·Immunology
Access TPO Antibody
FDA 510(k)
FDA Class 2
·Immunology
Access Thyroglobulin Antibody II
FDA 510(k)
FDA Class 2
·Immunology
Elecsys Anti-Tg
FDA 510(k)
FDA Class 2
·Immunology
Elecsys Anti-TSHR
FDA 510(k)
FDA Class 2
·Immunology
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Diagnostic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Dec 5, 2006 | Substantially Equivalent |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Jan 21, 2004 | Substantially Equivalent |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Dec 12, 2003 | Substantially Equivalent |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Oct 10, 2003 | Substantially Equivalent |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | Dec 17, 2002 | Substantially Equivalent |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Dec 9, 2002 | Substantially Equivalent |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
| K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS | May 30, 2002 | Substantially Equivalent |