FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K Number: K911153
·
Decision Jun 18, 1991
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
37
Review Days
95
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Basic Information
- Device Name
- MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
- K Number
- K911153
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Immunotech Corp.
- Date Received
- March 15, 1991
- Decision Date
- June 18, 1991
- Product Code
- LCM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Dec 18, 1990 | Substantially Equivalent |
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