HYW — Stain, Trichrome, Mallory'S Class I

FDA Device Classification

FDA product code HYW covers "Stain, Trichrome, Mallory'S", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HYW
Device Class
Class I
Regulation Number
864.1850
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K792706meridian diagnosticsPARA-PAK(WHEATLEY'S TRICHROME STAIN)January 24, 1980
K781062marion laboratoriesDROPPER, SOLUTION TRICHROME, CEPTI-SEALAugust 14, 1978