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510(k) K022757

SPIFE CK KIT, MODEL 3332, 3333 by Helena Laboratories — Product Code JHY

K022757 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPIFE CK KIT, MODEL 3332, 3333". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
August 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

Other clearances for product code JHY

  • K143720 — Dimension Vista MMB Assay (September 18, 2015)
  • K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CR (May 13, 2014)
  • K140404 — ELECSYS CK-MB STAT IMMUNOASSAY (May 8, 2014)
  • K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (October 18, 2013)
  • K070835 — OLYMPUS CK-MB REAGENT (June 4, 2007)
  • K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (August 29, 2002)
  • K974421 — ELECSYS CK-MB STAT (December 17, 1997)
  • K970343 — MMB METHOD (February 14, 1997)
  • K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (June 18, 1996)
  • K951638 — AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (May 2, 1995)

FDA data resources