510(k) K781516
K781516 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "TEST SYSTEM TISSUE CELL CULTURE SLIDE". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code KIY (Chamber, Slide Culture), a Class I device regulated under 21 CFR 864.2240. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1978
- Date Received
- August 31, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Slide Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type