510(k) K821687
K821687 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "REMOVAWELL TISSUE CULTURE PLATE W/LID". The FDA issued a decision of Substantially Equivalent on June 24, 1982. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Dynatech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1982
- Date Received
- June 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dish, Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type