510(k) K830542
K830542 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "HEMAQUIK II STAINING SOLUTION #55961". The FDA issued a decision of Substantially Equivalent on March 17, 1983. 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
- March 17, 1983
- Date Received
- February 22, 1983
- 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