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510(k) K990439

CARESIDE CK by Careside, Inc. — Product Code JHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1999
Date Received
February 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Careside, Inc.

  • K020484 — CARESIDE LDH (July 3, 2002)
  • K020486 — CARESIDE GGT (July 1, 2002)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K993771 — CARESIDE DIRECT BILIRUBIN (December 27, 1999)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K992475 — CARESIDE CO2, TOTAL (September 15, 1999)
  • K991717 — CARESIDE MG (August 10, 1999)

Other clearances for product code JHS

  • K160570 — Creatine Kinase (May 25, 2016)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K082226 — S40 CREATINE KINASE (CK) (September 18, 2008)
  • K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (August 21, 2006)
  • K990434 — CARESIDE CKMB (April 19, 1999)
  • K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (June 10, 1998)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIME (July 17, 1995)
  • K945083 — ACCESS CK-MB REAGENTS (November 21, 1994)
  • K943024 — KINASE ISOENZYME (August 2, 1994)