510(k) K771444

QUALICHECK TM by The London Co. — Product Code JJS

K771444 is an FDA 510(k) premarket notification submitted by The London Co. for the device "QUALICHECK TM". The FDA issued a decision of Substantially Equivalent on August 16, 1977. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. The London Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1977
Date Received
August 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type