FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DRUG STOP
K Number: K991465
·
Decision Dec 10, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
17
Applicant Total
27
Review Days
227
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Basic Information
- Device Name
- DRUG STOP
- K Number
- K991465
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Texas Immunology, Inc.
- Date Received
- April 27, 1999
- Decision Date
- December 10, 1999
- Product Code
- MVO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MVO), ordered by most recent decision date.
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
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AT HOME DRUG CUP, MODEL 9150X
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LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
FDA 510(k)
FDA Unclassified
·Unknown
PEACE OF MIND HOME DRUG TEST
FDA 510(k)
FDA Unclassified
·Unknown
AT HOME DRUG TEST, MODEL 9069
FDA 510(k)
FDA Unclassified
·Unknown
AT HOME DRUG TEST, MODEL 9064
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Texas Immunology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980153 | DRUG CHECK | Mar 27, 1998 | Substantially Equivalent |
| K973208 | FIRST SIGN | Oct 20, 1997 | Substantially Equivalent |
| K972094 | TARGET CARDIAC TROPONIN I TEST | Jul 23, 1997 | Substantially Equivalent |
| K963680 | TARGET MYOGLOBIN TEST | Feb 6, 1997 | Substantially Equivalent |
| K912246 | TARGET MICROALBUMINURIA TEST | Jul 19, 1991 | Substantially Equivalent |
| K910073 | TARGET ASO TEST | May 21, 1991 | Substantially Equivalent |
| K904105 | V-TREND TARGET RF TEST | Oct 15, 1990 | Substantially Equivalent |
| K892231 | V-TREND TARGET CRP TEST | Apr 21, 1989 | Substantially Equivalent |
| K890423 | V-TREND TARGET CRP TEST | Feb 17, 1989 | Substantially Equivalent |
| K890041 | V-TREND TARGET IM TEST | Jan 23, 1989 | Substantially Equivalent |