FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STARTOX DRUG OF ABUSE SCREENING TEST
K Number: K021006
·
Decision Jun 10, 2002
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
11
Review Days
74
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Basic Information
- Device Name
- STARTOX DRUG OF ABUSE SCREENING TEST
- K Number
- K021006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starplex Scientific, Inc.
- Date Received
- March 28, 2002
- Decision Date
- June 10, 2002
- 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 Starplex Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | Aug 13, 2003 | Substantially Equivalent |
| K022388 | STARTOX DRUG OF ABUSE SCREENING TEST (4) | Feb 27, 2003 | Substantially Equivalent |
| K962843 | MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | Sep 18, 1996 | Substantially Equivalent |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Apr 3, 1996 | Substantially Equivalent |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Feb 16, 1995 | Substantially Equivalent |
| K924361 | VACUPLUS TUBES WITH GREEN STOPPERS | Mar 1, 1993 | Substantially Equivalent |
| K924362 | VACUPLUS TUBES WITH LAVANDER STOPPERS | Mar 1, 1993 | Substantially Equivalent |
| K924364 | VACUPLUS TUBES WITH GREY STOPPERS | Mar 1, 1993 | Substantially Equivalent |
| K924363 | VACUPLUS(R) STAR-SEP(TM) | Feb 8, 1993 | Substantially Equivalent |
| K924365 | VACUPLUS TUBES WITH BRICK RED STOPPERS | Dec 28, 1992 | Substantially Equivalent |