FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DBSET MULTIDRUG SCREEN TEST KIT
K Number: K990681
·
Decision Jul 15, 1999
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
17
Review Days
135
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Basic Information
- Device Name
- DBSET MULTIDRUG SCREEN TEST KIT
- K Number
- K990681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ameritek, Inc.
- Date Received
- March 2, 1999
- Decision Date
- July 15, 1999
- Product Code
- DKZ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Ameritek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001215 | DBEST HCG 2 IU/ML TEST KIT | Jun 22, 2000 | Substantially Equivalent |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Sep 1, 1999 | Substantially Equivalent |
| K984269 | DBEST OCCULT BLOOD TEST KIT | May 11, 1999 | Substantially Equivalent |
| K983191 | DBEST COCAINE TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983190 | DBEST OPIATES TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983189 | DBEST METHAMPHETAMINES TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K981504 | DBEST AMPHETAMINES TEST KIT | Aug 6, 1998 | Substantially Equivalent |
| K974508 | DBEST ONE-STEP OVULATION TEST | Feb 2, 1998 | Substantially Equivalent |
| K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST | Dec 17, 1997 | Substantially Equivalent |