510(k) K962432

LIQUISPEX URINE (MICRO)ALBUMIN CONTROL by Clinical Controls, Inc. — Product Code JJX

K962432 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "LIQUISPEX URINE (MICRO)ALBUMIN CONTROL". The FDA issued a decision of Substantially Equivalent on Jul 5, 1996. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Clinical Controls, Inc. has 17 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 5, 1996
Date Received
Jun 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K962432. Report a data issue: hello@regdatalab.com.