510(k) K811084
K811084 is an FDA 510(k) premarket notification submitted by Labtronix Corp. for the device "LABTRONIX PLATELET COUNTER(L/O/C.)". The FDA issued a decision of Substantially Equivalent on July 23, 1981. The device falls under product code GLG (Platelet Counting, Manual), a Class I device regulated under 21 CFR 864.6160. Labtronix Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1981
- Date Received
- April 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Platelet Counting, Manual
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type