510(k) K812533
K812533 is an FDA 510(k) premarket notification submitted by Helmer Labs, Inc. for the device "PLATELET AGITATOR". The FDA issued a decision of Substantially Equivalent on September 29, 1981. The device falls under product code KSQ (Device, Blood Mixing And Blood Weighing), a Class I device regulated under 21 CFR 864.9195. Helmer Labs, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1981
- Date Received
- September 2, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Blood Mixing And Blood Weighing
- Device Class
- Class I
- Regulation Number
- 864.9195
- Review Panel
- HE
- Submission Type