510(k) K792706
K792706 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PARA-PAK(WHEATLEY'S TRICHROME STAIN)". The FDA issued a decision of Substantially Equivalent on January 24, 1980. The device falls under product code HYW (Stain, Trichrome, Mallory'S), a Class I device regulated under 21 CFR 864.1850. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1980
- Date Received
- December 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stain, Trichrome, Mallory'S
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type