510(k) K843919
K843919 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "SPOTTEST LOEFFLER METHYLENE BLUE STAIN". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code KFC (Methylene Blue, Tissue Stain), a Class I device regulated under 21 CFR 864.1850. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1984
- Date Received
- October 5, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methylene Blue, Tissue Stain
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type