Kinase Isoenzyme
FDA 510(k) K943024 · Dupont Medical Products
510(k) numberK943024
Submission
- Device name
- Kinase Isoenzyme
- Applicant
- Dupont Medical Products
Wilmington, DE, US - Received
- May 26, 1994
- Decision date
- August 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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| K952250 | Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High…JHS · Traditional | Dade Intl., Inc. | 07/17/1995SE |
| K945083 | Access Ck-Mb ReagentsJHS · Traditional | Bio-Rad Laboratories, Inc. | 11/21/1994SE |
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| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | 06/23/1995SE |
| K945280 | Dupont Dimension C-Reactive Protein MethodDCK · Traditional | 03/09/1995SE |
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| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | 10/20/1994SE |
| K941146 | Dupont Aca Plus Thyroid Stimulating Hormone SystemJLW · Traditional | 10/03/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | 09/09/1994SE |
Questions and answers
When was Kinase Isoenzyme cleared by the FDA?
Kinase Isoenzyme (K943024) received a 510(k) decision of Substantially Equivalent on August 2, 1994, 68 days after the submission was received.
What is the product code of K943024?
The FDA product code is JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.