FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K Number: K992207
·
Decision Jul 22, 1999
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
26
Review Days
22
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Basic Information
- Device Name
- QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
- K Number
- K992207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntron Bioresearch, Inc.
- Date Received
- June 30, 1999
- Decision Date
- July 22, 1999
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
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Emit II Plus Cocaine Metabolite Assay
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Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
FDA 510(k)
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·Clinical Toxicology
Other Clearances by Syntron Bioresearch, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | Oct 29, 1999 | Substantially Equivalent |
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | Oct 29, 1999 | Substantially Equivalent |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | Sep 20, 1999 | Substantially Equivalent |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | Sep 2, 1999 | Substantially Equivalent |
| K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | Jun 24, 1999 | Substantially Equivalent |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Nov 18, 1998 | Substantially Equivalent |
| K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | May 26, 1998 | Substantially Equivalent |
| K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | May 7, 1998 | Substantially Equivalent |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | Mar 3, 1998 | Substantially Equivalent |
| K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST | Feb 12, 1998 | Substantially Equivalent |