FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
K Number: DEN050002
·
Decision May 19, 2005
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
1
Applicant Total
124
Review Days
42
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Basic Information
- Device Name
- LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
- K Number
- DEN050002
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.6030
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Wako Chemicals USA, Inc.
- Date Received
- April 7, 2005
- Decision Date
- May 19, 2005
- Product Code
- NSF
- 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 |
|---|---|---|---|
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NSF), ordered by most recent decision date.
View allOther Clearances by Wako Chemicals USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | Feb 23, 2011 | Substantially Equivalent |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | Jul 18, 2008 | Substantially Equivalent |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | Jul 17, 2008 | Substantially Equivalent |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR | Feb 23, 2007 | Substantially Equivalent |
| K062368 | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 | Jan 31, 2007 | Substantially Equivalent |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | Dec 30, 2005 | Substantially Equivalent |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | Dec 30, 2005 | Substantially Equivalent |
| K042551 | MULTI-CHEM CALIBRATOR A | Nov 16, 2004 | Substantially Equivalent |
| K042550 | MULTI-LIPID CALIBRATOR | Nov 8, 2004 | Substantially Equivalent |
| K042549 | MULTI CHEM CAL B | Nov 8, 2004 | Substantially Equivalent |