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510(k) K800684

REAGENT FOR DETERM. CREATINE PHOSPHOKINA by Diagnostic Solutions, Inc. — Product Code JHY

K800684 is an FDA 510(k) premarket notification submitted by Diagnostic Solutions, Inc. for the device "REAGENT FOR DETERM. CREATINE PHOSPHOKINA". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Diagnostic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
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 Diagnostic Solutions, Inc.

  • K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION (January 11, 1994)
  • K924398 — UNI-CHECK REAGENT STRIP (December 23, 1992)
  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800677 — REAGENTS FOR DETERM. SERUM IRON IN HUMAN (May 28, 1980)
  • K800675 — REAGENTS FOR DETERM. TOTAL BILIRUBIN (May 28, 1980)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)
  • K800678 — REAGENTS FOR DETERM. ALBUMIN IN HUMAN (May 28, 1980)

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)
  • K970343 — MMB METHOD (February 14, 1997)
  • K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (June 18, 1996)

FDA data resources