FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUORETEC-M
K Number: K770833
·
Decision Jun 8, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
30
Review Days
33
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Basic Information
- Device Name
- FLUORETEC-M
- K Number
- K770833
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3255
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pfizer, Inc.
- Date Received
- May 6, 1977
- Decision Date
- June 8, 1977
- Product Code
- GMY
- 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 |
|---|---|---|---|
| GMY | Antisera, Fluorescent, All Types, Escherichia Coli | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMY), ordered by most recent decision date.
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