510(k) K842537

VON WILLEBRAND FACTOR ANTIGEN SCREEN by American Dade — Product Code ICF

K842537 is an FDA 510(k) premarket notification submitted by American Dade for the device "VON WILLEBRAND FACTOR ANTIGEN SCREEN". The FDA issued a decision of Substantially Equivalent on Oct 1, 1984. The device falls under product code ICF (Crystal Violet For Histology), a Class I device regulated under 21 CFR 864.1850. American Dade has 148 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 1, 1984
Date Received
Jun 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Crystal Violet For Histology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K842537. Report a data issue: hello@regdatalab.com.