510(k) K842743
K842743 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "NEW METHYLENE BLUE N". The FDA issued a decision of Substantially Equivalent on August 12, 1984. The device falls under product code KFC (Methylene Blue, Tissue Stain), a Class I device regulated under 21 CFR 864.1850. E K Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1984
- Date Received
- July 13, 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