510(k) K823329
K823329 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "PAPINCOLABU STAIN EA-36/50/65 & OG-6". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code HZL (Phloxine B), 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
- December 28, 1982
- Date Received
- November 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phloxine B
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type