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510(k) K881200

CHLORIDE LIQUID STABLE REAGENT SET by Medical Analysis Systems, Inc. — Product Code CHJ

K881200 is an FDA 510(k) premarket notification submitted by Medical Analysis Systems, Inc. for the device "CHLORIDE LIQUID STABLE REAGENT SET". The FDA issued a decision of Substantially Equivalent on April 28, 1988. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Medical Analysis Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mercuric Thiocyanate, Colorimetry, Chloride
Device Class
Class II
Regulation Number
862.1170
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)

Other clearances for product code CHJ

  • K010670 — PICCOLO CHLORIDE TEST SYSTEM (April 26, 2001)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K943006 — CHLORIDE QVET (December 7, 1994)
  • K934136 — OLYMPUS CHLORIDE REAGENT, MODIFICATION (November 5, 1993)
  • K932528 — OLYMPUS CHLORID REAGENT, MODIFIED (September 17, 1993)
  • K925338 — OLYMPUS CHLORIDE REAGENT (December 11, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923610 — OLYMPUS CHLORIDE REAGENT (October 2, 1992)
  • K923036 — URINE CHLORIDE (September 9, 1992)
  • K911297 — CHLORIDE REAGENT (April 16, 1991)

FDA data resources