510(k) K822602
K822602 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "HEMACOUNT WRIGHT GIEMSA STAIN PACK". The FDA issued a decision of Substantially Equivalent on September 17, 1982. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Accra Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1982
- Date Received
- August 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Nonfetal
- Device Class
- Class II
- Regulation Number
- 892.1540
- Review Panel
- RA
- Submission Type