FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K Number: K982024
·
Decision Jun 29, 1998
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
107
Review Days
20
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Basic Information
- Device Name
- OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
- K Number
- K982024
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Analysis Systems, Inc.
- Date Received
- June 9, 1998
- Decision Date
- June 29, 1998
- Product Code
- DIF
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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Other Clearances by Medical Analysis Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | Nov 5, 2004 | Substantially Equivalent |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | Aug 16, 2004 | Substantially Equivalent |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | Apr 28, 2004 | Substantially Equivalent |
| K032826 | MAS PAR TDM | Oct 9, 2003 | Substantially Equivalent |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | Aug 19, 2003 | Substantially Equivalent |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | Jul 16, 2003 | Substantially Equivalent |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | Jul 1, 2003 | Substantially Equivalent |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Jul 1, 2003 | Substantially Equivalent |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | May 30, 2003 | Substantially Equivalent |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | Apr 28, 2003 | Substantially Equivalent |