FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIKPAC II ONE STEP OPIATE TEST
K Number: K972405
·
Decision Aug 8, 1997
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
13
Review Days
43
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Basic Information
- Device Name
- QUIKPAC II ONE STEP OPIATE TEST
- K Number
- K972405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drial Consultants, Inc.
- Date Received
- June 26, 1997
- Decision Date
- August 8, 1997
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by Drial Consultants, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973269 | QUIKSTRIP ONE STEP BENZODIAZEPINE TEST | Feb 25, 1998 | Substantially Equivalent |
| K973326 | QUIKPAC II ONE STEP BENZODIAZEPINE TEST | Feb 24, 1998 | Substantially Equivalent |
| K973047 | ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST | Oct 2, 1997 | Substantially Equivalent |
| K972059 | QUIKPAC II ONE STEP COCAINE TEST | Aug 28, 1997 | Substantially Equivalent |
| K972571 | QUIKSTRIP ONE STEP OPIATES TEST | Aug 20, 1997 | Substantially Equivalent |
| K971926 | QUIKSTRIP ONE STEP COCAINE TEST | Jul 14, 1997 | Substantially Equivalent |
| K970395 | QUIKSTRIP ONE STEP METHAMPHETAMINE | Jun 26, 1997 | Substantially Equivalent |
| K971218 | QUIKSTRIP ONE STEP AMPHETAMINE TEST | May 30, 1997 | Substantially Equivalent |
| K971109 | QUIKPAC II ONE STEP AMPHETAMINE TEST | May 14, 1997 | Substantially Equivalent |
| K970724 | QUICKPAC II ONE STEP METHAMPHETAMINE TEST | May 13, 1997 | Substantially Equivalent |