FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A1CNOW FOR HOME AND PROFESSIONAL USE
K Number: K033847
·
Decision Dec 23, 2003
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
11
Review Days
12
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Basic Information
- Device Name
- A1CNOW FOR HOME AND PROFESSIONAL USE
- K Number
- K033847
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Metrika, Inc.
- Date Received
- December 11, 2003
- Decision Date
- December 23, 2003
- Product Code
- LCP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Metrika, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051321 | INVIEW | Jun 13, 2005 | Substantially Equivalent |
| K022661 | A1CNOW FOR HOME USE | Dec 13, 2002 | Substantially Equivalent |
| K020234 | A1CNOW FOR RX HOME USE | Feb 15, 2002 | Substantially Equivalent |
| K020235 | A1CNOW FOR PROFESSIONAL USE | Feb 15, 2002 | Substantially Equivalent |
| K000885 | DRX HBA1C - FOR PRESCRIPTION HOME USE | Sep 26, 2000 | Substantially Equivalent |
| K000887 | DRX HBA1C | Jul 26, 2000 | Substantially Equivalent |
| K992997 | OSTEOMARK NTX POC | Nov 9, 1999 | Substantially Equivalent |
| K991532 | DRX QT. HCG | Sep 17, 1999 | Substantially Equivalent |
| K984530 | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE | Aug 10, 1999 | Substantially Equivalent |
| K991917 | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET | Jul 12, 1999 | Substantially Equivalent |