510(k) K873137
K873137 is an FDA 510(k) premarket notification submitted by In Vitro Scientific Products for the device "IN VITRO 2.5X ROLLER BOTTLE". The FDA issued a decision of Substantially Equivalent on August 24, 1987. The device falls under product code KJC (Bottle, Roller, Tissue Culture), a Class I device regulated under 21 CFR 864.2240.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1987
- Date Received
- August 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Roller, Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type