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510(k) K970343

MMB METHOD by Dade Chemistry Systems, Inc. — Product Code JHY

K970343 is an FDA 510(k) premarket notification submitted by Dade Chemistry Systems, Inc. for the device "MMB METHOD". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Dade Chemistry Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1997
Date Received
January 29, 1997
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 Dade Chemistry Systems, Inc.

  • K973650 — TROPONIN (TROP) METHOD (October 20, 1997)
  • K973099 — PROSTATE SPECIFIC ANTIGEN CONTROL (September 29, 1997)
  • K973100 — PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (September 29, 1997)
  • K973101 — PROSTATE SPECIFIC ANTIGEN METHOD (September 18, 1997)
  • K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (April 28, 1997)
  • K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD (March 10, 1997)
  • K970336 — MMB CALIBRATOR (March 3, 1997)
  • K970393 — THYROID STIMULATING HORMONE METHOD (March 3, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K970389 — THYROID CALIBRATOR (February 18, 1997)

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)
  • K022757 — SPIFE CK KIT, MODEL 3332, 3333 (October 11, 2002)
  • K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (August 29, 2002)
  • K974421 — ELECSYS CK-MB STAT (December 17, 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