FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
K Number: K830479
·
Decision Mar 10, 1983
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
49
Review Days
23
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Basic Information
- Device Name
- ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
- K Number
- K830479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- February 15, 1983
- Decision Date
- March 10, 1983
- Product Code
- DKN
- 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 |
|---|---|---|---|
| DKN | Radioimmunoassay, Barbiturate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKN), ordered by most recent decision date.
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
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FDA Class 2
·Clinical Toxicology
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AGGLUTEX BARBITURATES TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Hoffmann-La Roche, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | Jun 25, 1985 | Substantially Equivalent |
| K831694 | RENAK | Jul 19, 1983 | Substantially Equivalent |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | Mar 24, 1983 | Substantially Equivalent |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Mar 24, 1983 | Substantially Equivalent |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Mar 24, 1983 | Substantially Equivalent |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Mar 24, 1983 | Substantially Equivalent |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Mar 24, 1983 | Substantially Equivalent |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Mar 24, 1983 | Substantially Equivalent |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Jan 7, 1983 | Substantially Equivalent |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Jan 7, 1983 | Substantially Equivalent |