FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WAKO AUTOKIT GLUCOSE
K Number: K950172
·
Decision Oct 5, 1995
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
121
Review Days
261
Basic Information
- Device Name
- WAKO AUTOKIT GLUCOSE
- K Number
- K950172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- WAKO CHEMICALS, USA, INC.
- Date Received
- January 17, 1995
- Decision Date
- October 5, 1995
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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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 |