510(k) K832428
K832428 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "PLATELET AGGREGATION REAGENT SET". The FDA issued a decision of Substantially Equivalent on Oct 20, 1983. The device falls under product code GHR (Reagent, Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Helena Laboratories has 281 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 1983
- Date Received
- Jul 22, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Reagent, Platelet Aggregation
- Device Class
- Class II
- Regulation Number
- 864.5700
- Review Panel
- HE
- Submission Type
- 510(k)