FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMVIEW-10
K Number: K042641
·
Decision Jan 7, 2005
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
5
Review Days
102
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Basic Information
- Device Name
- CHEMVIEW-10
- K Number
- K042641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cenogenics Corp.
- Date Received
- September 27, 2004
- Decision Date
- January 7, 2005
- Product Code
- JIL
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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Other Clearances by Cenogenics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | Apr 17, 2003 | Substantially Equivalent |
| K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | Aug 26, 1999 | Substantially Equivalent |
| K894793 | MONODEX | Aug 21, 1989 | Substantially Equivalent |
| K843680 | URI-VAL | Mar 29, 1985 | Substantially Equivalent |