510(k) K850800
K850800 is an FDA 510(k) premarket notification submitted by Berwick Medical Products, Inc. for the device "DROPSTIRS - PLASTIC DISPOSABLE PIPET". The FDA issued a decision of Substantially Equivalent on April 2, 1985. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Berwick Medical Products, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1985
- Date Received
- February 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Station, Pipetting And Diluting, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type