Reagent for Determ. Creatine Phosphokina
FDA 510(k) K800684 · Diagnostic Solutions, Inc.
510(k) numberK800684
Submission
- Device name
- Reagent for Determ. Creatine Phosphokina
- Applicant
- Diagnostic Solutions, Inc.
Mchenry, IL, US - Received
- March 26, 1980
- Decision date
- May 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K140404 | Elecsys Ck-Mb Stat ImmunoassayJHY · Special | Roche Diagnostics | 05/08/2014SE |
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| K022757 | Spife CK Kit, Model 3332, 3333JHY · Traditional | Helena Laboratories | 10/11/2002SE |
| K022654 | Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special | Roche Diagnostics Corp. | 08/29/2002SE |
| K974421 | Elecsys Ck-Mb StatJHY · Traditional | Boehringer Mannheim Corp. | 12/17/1997SE |
| K970343 | MMB MethodJHY · Traditional | Dade Chemistry Systems, Inc. | 02/14/1997SE |
| K961412 | Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional | Bayer Corp. | 06/18/1996SE |
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|---|---|---|
| K934892 | Relief Plus One Reagent Strip ModificationCGA · Traditional | 01/11/1994SE |
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| K921825 | Quick-Check II Reagent StripCGA · Traditional | 08/18/1992SE |
| K800689 | Reagent for Determ. Glutamic-Pyruvic-CKA · Traditional | 05/30/1980SE |
| K800681 | Reagents for Determ. CO2 in Human SerumKMS · Traditional | 05/30/1980SE |
| K800692 | Reagent for Determ. Potassium/In HumanCEM · Traditional | 05/28/1980SE |
| K800691 | Reagent for Determ. Lactate/DehydrogenasCFJ · Traditional | 05/28/1980SE |
| K800690 | Reagent for Determ. Inorganic/PhosphorusCEO · Traditional | 05/28/1980SE |
| K800688 | Reagent for Determ. Glutamic-OxaloaceticCIT · Traditional | 05/28/1980SE |
| K800687 | Reagent for Determ. Glucose in H/SerumCGA · Traditional | 05/28/1980SE |
Questions and answers
When was Reagent for Determ. Creatine Phosphokina cleared by the FDA?
Reagent for Determ. Creatine Phosphokina (K800684) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 63 days after the submission was received.
What is the product code of K800684?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.