MMB Method

FDA 510(k) K970343 · Dade Chemistry Systems, Inc.

Substantially Equivalent

510(k) numberK970343

Submission

Device name
MMB Method
Applicant
Dade Chemistry Systems, Inc.
Glasgow, DE, US
Received
January 29, 1997
Decision date
February 14, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JHY – Colorimetric Method, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

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K140404Elecsys Ck-Mb Stat ImmunoassayJHY · Special Roche Diagnostics05/08/2014SE
K132571Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional Roche Diagnostics10/18/2013SE
K070835Olympus Ck-Mb ReagentJHY · Traditional Olympus Life & Material Science Europa GmbH (Irish06/04/2007SE
K022757Spife CK Kit, Model 3332, 3333JHY · Traditional Helena Laboratories10/11/2002SE
K022654Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special Roche Diagnostics Corp.08/29/2002SE
K974421Elecsys Ck-Mb StatJHY · Traditional Boehringer Mannheim Corp.12/17/1997SE
K961412Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional Bayer Corp.06/18/1996SE
K951638Auraflex Ck-Mb 200TEST Pack, Calibrator PackJHY · Traditional Organon Teknika Corp.05/02/1995SE

More from Organon Teknika Corp.

510(k)DeviceDecision
K973650Troponin (Trop) MethodMMI · Traditional 10/20/1997SE
K973100Prostate Specific Antigen (Psa) CalibratorJIT · Traditional 09/29/1997SE
K973099Prostate Specific Antigen ControlJJX · Traditional 09/29/1997SE
K973101Prostate Specific Antigen MethodLTJ · Traditional 09/18/1997SE
K971141FT4 Method for the Dimension RXL Clinical Chemistry SystemCEC · Traditional 04/28/1997SE
K970387Human Chorionic Gonadotropin MethodDHA · Traditional 03/10/1997SE
K970393Thyroid Stimulating Hormone MethodJLW · Traditional 03/03/1997SE
K970336MMB CalibratorJIT · Traditional 03/03/1997SE
K970396Human Chorionic Gonadotropin CalibratorJIW · Traditional 02/20/1997SE
K970389Thyroid CalibratorJIT · Traditional 02/18/1997SE

Questions and answers

When was MMB Method cleared by the FDA?

MMB Method (K970343) received a 510(k) decision of Substantially Equivalent on February 14, 1997, 16 days after the submission was received.

What is the product code of K970343?

The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.