FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K Number: K022603
·
Decision Aug 21, 2002
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
321
Review Days
15
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Basic Information
- Device Name
- IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
- K Number
- K022603
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Products Corp.
- Date Received
- August 6, 2002
- Decision Date
- August 21, 2002
- Product Code
- CEW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
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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 |
| 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 |
| K021206 | IMMULITE 2000 SPECIFIC ALLERGENS | May 30, 2002 | Substantially Equivalent |