510(k) K831502
K831502 is an FDA 510(k) premarket notification submitted by Flaitron Laboratories, Inc. for the device "NEPHROLYTE". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code KFC (Methylene Blue, Tissue Stain), a Class I device regulated under 21 CFR 864.1850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1983
- Date Received
- May 11, 1983
- 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