510(k) K792703

LACTO-PHENOL ANALINE BLUE FLUID by Meridian Diagnostics, Inc. — Product Code KEQ

K792703 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "LACTO-PHENOL ANALINE BLUE FLUID". The FDA issued a decision of Substantially Equivalent on January 24, 1980. The device falls under product code KEQ (Media, Mounting, Water Soluble), a Class I device regulated under 21 CFR 864.4010. 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
Media, Mounting, Water Soluble
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type