510(k) K926320

REFLAB SYSTEM PACK LIQUID CO2 REAGENT by Medical Analysis Systems, Inc. — Product Code CHS

K926320 is an FDA 510(k) premarket notification submitted by Medical Analysis Systems, Inc. for the device "REFLAB SYSTEM PACK LIQUID CO2 REAGENT". The FDA issued a decision of Substantially Equivalent on February 3, 1993. The device falls under product code CHS (Coulometric Method, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Medical Analysis Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 3, 1993
Date Received: December 15, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Coulometric Method, Carbon-Dioxide
Device Class: Class II
Regulation Number: 862.1160
Review Panel: CH
Submission Type

Other clearances by Medical Analysis Systems, Inc.

K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (November 5, 2004)
K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, (August 16, 2004)
K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (April 28, 2004)
K032826 — MAS PAR TDM (October 9, 2003)
K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (August 19, 2003)
K031890 — MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (July 16, 2003)
K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (July 1, 2003)
K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL (July 1, 2003)
K031364 — MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (May 30, 2003)
K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (April 28, 2003)

510(k) K926320

Clearance Details

Device Classification

Other clearances by Medical Analysis Systems, Inc.

Other clearances for product code CHS

FDA data resources