510(k) K821457
K821457 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "HEMACOUNT WRIGHTS STAIN PACK II #55952". The FDA issued a decision of Substantially Equivalent on June 1, 1982. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. Accra Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1982
- Date Received
- May 17, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wright'S Stain
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type