510(k) K870451
K870451 is an FDA 510(k) premarket notification submitted by Bioclinical Laboratory Services, Inc. for the device "SKIN GRAFT PRESERVATION MEDIUM (TISSUE)". The FDA issued a decision of Substantially Equivalent on May 26, 1987. 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. Bioclinical Laboratory Services, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1987
- Date Received
- February 3, 1987
- 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