FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
K Number: K931557
·
Decision Mar 11, 1994
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
4
Review Days
346
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Basic Information
- Device Name
- FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
- K Number
- K931557
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fuller Laboratories, Inc.
- Date Received
- March 30, 1993
- Decision Date
- March 11, 1994
- Product Code
- GRZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GRZ | Antisera, Fluorescent, All, Mycoplasma Spp. | FDA class 1 | Microbiology |
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