FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
K Number: K023648
·
Decision May 6, 2003
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
17
Review Days
188
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Basic Information
- Device Name
- VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
- K Number
- K023648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sun Biomedical Laboratories, Inc.
- Date Received
- October 30, 2002
- Decision Date
- May 6, 2003
- Product Code
- LDJ
- 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
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Other Clearances by Sun Biomedical Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023856 | VISUALINE METHADONE DIPSTRIPTEST | Aug 25, 2003 | Substantially Equivalent |
| K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES | Apr 25, 2002 | Substantially Equivalent |
| K020136 | VISUALINE BARBITURATES DIPSTRIP TEST | Mar 20, 2002 | Substantially Equivalent |
| K011499 | VISUALINE AMPHETAMINE DIPSTRIP ASSAY | Jul 17, 2001 | Substantially Equivalent |
| K010177 | VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY | May 17, 2001 | Substantially Equivalent |
| K993485 | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE | Dec 27, 1999 | Substantially Equivalent |
| K983790 | VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE | Mar 1, 1999 | Substantially Equivalent |
| K981314 | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE | Sep 4, 1998 | Substantially Equivalent |
| K972032 | VISUALINE II METHAMPHETIMINE | Aug 12, 1997 | Substantially Equivalent |
| K963606 | VISUALINE COMBO V (COCAINE/THC) TEST | Oct 30, 1996 | Substantially Equivalent |