510(k) K893519
K893519 is an FDA 510(k) premarket notification submitted by Statlabs, Inc. for the device "TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code KZB (Automated Colony Counter), a Class I device regulated under 21 CFR 866.2170.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1989
- Date Received
- May 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Colony Counter
- Device Class
- Class I
- Regulation Number
- 866.2170
- Review Panel
- MI
- Submission Type