FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K Number: K902194
·
Decision Jul 17, 1990
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
37
Review Days
62
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Basic Information
- Device Name
- MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
- K Number
- K902194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Immunotech Corp.
- Date Received
- May 16, 1990
- Decision Date
- July 17, 1990
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Jan 30, 1991 | Substantially Equivalent |
| K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT | Dec 20, 1990 | Substantially Equivalent |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Dec 18, 1990 | Substantially Equivalent |