FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WAKO LDH CII TEST
K Number: K842452
·
Decision Aug 15, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
121
Review Days
54
Basic Information
- Device Name
- WAKO LDH CII TEST
- K Number
- K842452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- WAKO CHEMICALS, USA, INC.
- Date Received
- June 22, 1984
- Decision Date
- August 15, 1984
- Product Code
- CFH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFH), ordered by most recent decision date.
SPOTCHEM II LDH TEST
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IQ LDH
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LACTATE DEHYDROGENASE (LDH-L)
FDA 510(k)
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·Clinical Chemistry
LACTATE DEHYDROGENASE (LDH) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by WAKO CHEMICALS, USA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| DEN050002 | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS | May 19, 2005 | Unknown |
| K042551 | MULTI-CHEM CALIBRATOR A | Nov 16, 2004 | Substantially Equivalent |
| K042549 | MULTI CHEM CAL B | Nov 8, 2004 | Substantially Equivalent |
| K042550 | MULTI-LIPID CALIBRATOR | Nov 8, 2004 | Substantially Equivalent |
| K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 | May 17, 2004 | Substantially Equivalent |
| K033860 | AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR | Apr 23, 2004 | Substantially Equivalent |