FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
K Number: K981197
·
Decision Jun 16, 1998
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
14
Review Days
75
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Basic Information
- Device Name
- ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
- K Number
- K981197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tcpi, Inc.
- Date Received
- April 2, 1998
- Decision Date
- June 16, 1998
- 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 Tcpi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981363 | ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST | Dec 22, 1998 | Substantially Equivalent |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | Oct 7, 1998 | Substantially Equivalent |
| K980776 | ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST | Apr 29, 1998 | Substantially Equivalent |
| K951853 | ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) | Aug 20, 1996 | Substantially Equivalent |
| K954968 | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST | Jul 26, 1996 | Substantially Equivalent |
| K954685 | URITEST - NITRITE IN URINE TEST | Jul 22, 1996 | Substantially Equivalent |
| K955353 | ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT | Mar 19, 1996 | Substantially Equivalent |
| K951892 | ONE STEP URINE DRUG OF ABUSE COCAINE TEST | Aug 17, 1995 | Substantially Equivalent |
| K952096 | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) | Aug 17, 1995 | Substantially Equivalent |
| K941765 | HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE | Oct 20, 1994 | Substantially Equivalent |