510(k) K761303
K761303 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "IMMU-SAL IMMUNOHEMATOLOGICAL SALINE". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code KSS (Supplies, Blood-Bank), a Class I device regulated under 21 CFR 864.9050. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1976
- Date Received
- December 22, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Supplies, Blood-Bank
- Device Class
- Class I
- Regulation Number
- 864.9050
- Review Panel
- HE
- Submission Type