510(k) K870938
K870938 is an FDA 510(k) premarket notification submitted by Hyclone Laboratories, Inc. for the device "FETAL BOVINE SERUM". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800. Hyclone Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1987
- Date Received
- March 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sera, Animal And Human
- Device Class
- Class I
- Regulation Number
- 864.2800
- Review Panel
- PA
- Submission Type