510(k) K770833
K770833 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "FLUORETEC-M". The FDA issued a decision of Substantially Equivalent on June 8, 1977. The device falls under product code GMY (Antisera, Fluorescent, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Pfizer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1977
- Date Received
- May 6, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All Types, Escherichia Coli
- Device Class
- Class I
- Regulation Number
- 866.3255
- Review Panel
- MI
- Submission Type