FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UTAK-STABBS TOXICOLOGY CONTROL
K Number: K862420
·
Decision Aug 4, 1986
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
23
Review Days
40
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Basic Information
- Device Name
- UTAK-STABBS TOXICOLOGY CONTROL
- K Number
- K862420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Utak Laboratories, Inc.
- Date Received
- June 25, 1986
- Decision Date
- August 4, 1986
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Utak Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL | Apr 12, 1991 | Substantially Equivalent |
| K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL | Oct 6, 1988 | Substantially Equivalent |
| K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL | Nov 13, 1986 | Substantially Equivalent |
| K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL | Nov 13, 1986 | Substantially Equivalent |
| K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL | Nov 5, 1986 | Substantially Equivalent |
| K831736 | TRICYCLIC ANTIDEPRESSANTS | Jul 28, 1983 | Substantially Equivalent |
| K831738 | CAFFINE TOXICOLOGY CONTROL | Jul 26, 1983 | Substantially Equivalent |
| K831735 | MAPROTILINE | Jul 26, 1983 | Substantially Equivalent |
| K831741 | FLURAZEPAM TOXICOLOGY CONTROL | Jul 26, 1983 | Substantially Equivalent |
| K831734 | AMOXAPINE 8-HYDRO-XYAMOXAPINE | Jul 26, 1983 | Substantially Equivalent |