510(k) K792483
K792483 is an FDA 510(k) premarket notification submitted by Laboratory Products, Inc. for the device "STAINS, COUNTERSTAINS & GEN. PURPOSE". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code ICL (Carbol Fuchsin), a Class I device regulated under 21 CFR 864.1850. Laboratory Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1979
- Date Received
- November 19, 1979
- 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