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510(k) K800028

WORTHINGTON FLOZYME* CPK (340NM) by Worthington Diagnostic Systems — Product Code JHS

K800028 is an FDA 510(k) premarket notification submitted by Worthington Diagnostic Systems for the device "WORTHINGTON FLOZYME* CPK (340NM)". The FDA issued a decision of Substantially Equivalent on January 21, 1980. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Worthington Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1980
Date Received
January 7, 1980
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 Worthington Diagnostic Systems

  • K833708 — COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (January 4, 1984)
  • K832748 — COMPUR* EASYTOUCH TOTAL BILIRUBIN (October 14, 1983)
  • K832749 — EASYTOUCH BUN REAGENT SET (October 14, 1983)
  • K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT (October 14, 1983)
  • K832427 — EASYTOUCH TROMBOPLASTIN REAGENT (October 14, 1983)
  • K832750 — EASYTOUCH HEMOGLOBIN REAGENT (September 26, 1983)
  • K832426 — EASYTOUCH TRIGLYCERIDES REAGENT SET (September 12, 1983)
  • K831477 — DEMAND ANALYZER SYSTEM (June 17, 1983)
  • K831318 — COMPUR* M1100 HEMATRCRIT SYSTEM (June 8, 1983)
  • K831227 — COMPUR EASY TOUCH CHEMISTRY ANALYZER- (June 2, 1983)

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)
  • K990439 — CARESIDE CK (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)

FDA data resources