510(k) K884654
K884654 is an FDA 510(k) premarket notification submitted by Hyclone Laboratories, Inc. for the device "ALPHACALF SERUM". The FDA issued a decision of Substantially Equivalent on November 30, 1988. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220. Hyclone Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1988
- Date Received
- November 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media And Components, Synthetic Cell And Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2220
- Review Panel
- PA
- Submission Type