510(k) K771390
K771390 is an FDA 510(k) premarket notification submitted by Harleco for the device "HISTOCHEMICAL AFB DEMONSTRATION". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code ICL (Carbol Fuchsin), a Class I device regulated under 21 CFR 864.1850. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1977
- Date Received
- July 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carbol Fuchsin
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type