Cardio Rep CK Isoenzyme Kit - 3310
FDA 510(k) K931050 · Helena Laboratories
510(k) numberK931050
Submission
- Device name
- Cardio Rep CK Isoenzyme Kit - 3310
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 1, 1993
- Decision date
- April 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHW – U.V. Method, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K162526 | Creatine Kinase-MBJHW · Traditional | Roche Diagnostics | 05/26/2017SE |
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| K122083 | Elitech Clinical Systems CK Nac SLJHW · Traditional | Elitechgroup | 08/22/2012SE |
| K023744 | Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional | Wiener Laboratories Saic | 01/03/2003SE |
| K003158 | Roche Diagnostics Ck-MbJHW · Traditional | Roche Diagnostics Corp. | 12/18/2000SE |
| K961501 | Elecsys Ck-MbJHW · Traditional | Boehringer Mannheim Corp. | 06/11/1996SE |
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional | Miles, Inc. | 03/13/1995SE |
| K944325 | Lifesign, Care Point, Vitalsign, AccusignJHW · Traditional | Princeton BioMeditech Corp. | 02/22/1995SE |
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | Biochemical Trade, Inc. | 11/21/1994SE |
| K935924 | Axsym Ck-MbJHW · Traditional | Abbott Laboratories | 06/21/1994SE |
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Questions and answers
When was Cardio Rep CK Isoenzyme Kit - 3310 cleared by the FDA?
Cardio Rep CK Isoenzyme Kit - 3310 (K931050) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 50 days after the submission was received.
What is the product code of K931050?
The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.