FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRX QT. HCG
K Number: K991532
·
Decision Sep 17, 1999
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
11
Review Days
137
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Basic Information
- Device Name
- DRX QT. HCG
- K Number
- K991532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Metrika, Inc.
- Date Received
- May 3, 1999
- Decision Date
- September 17, 1999
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Metrika, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051321 | INVIEW | Jun 13, 2005 | Substantially Equivalent |
| K033847 | A1CNOW FOR HOME AND PROFESSIONAL USE | Dec 23, 2003 | 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 |
| 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 |