510(k) K792549

FAT RED 7B STAIN SET by Electrophoresis Corp. of America — Product Code HYD

K792549 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "FAT RED 7B STAIN SET". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code HYD (Fast Red Salt B), a Class I device regulated under 21 CFR 864.1850. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1979
Date Received
December 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fast Red Salt B
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type