FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
K Number: K990873
·
Decision Sep 1, 1999
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
12
Applicant Total
17
Review Days
169
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Basic Information
- Device Name
- DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
- K Number
- K990873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1510
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ameritek, Inc.
- Date Received
- March 16, 1999
- Decision Date
- September 1, 1999
- Product Code
- JMT
- 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 |
|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Ameritek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K974508 | DBEST ONE-STEP OVULATION TEST | Feb 2, 1998 | Substantially Equivalent |
| K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST | Dec 17, 1997 | Substantially Equivalent |