CPK - Isoenzymes
FDA 510(k) K760028 · Harleco
510(k) numberK760028
Submission
- Device name
- CPK - Isoenzymes
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 14, 1976
- Decision date
- September 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHT – Chromatographic Separation, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022409 | Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional | Spectral Diagnostics, Inc. | 09/30/2002SE |
| K991299 | Modification to Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi…JHT · Traditional | Princeton BioMeditech Corp. | 05/28/1999SE |
| K930359 | Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional | Helena Laboratories | 04/12/1993SE |
| K904866 | Coulter Ck-Mb Isoenzyme ReagentJHT · Traditional | Coulter Electronics, Inc. | 12/13/1990SE |
| K904721 | DSL Ck-Mb (DSL #3200)JHT · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 05/15/1990SE |
| K896170 | Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional | Helena Laboratories | 02/16/1990SE |
| K881168 | Creatine Kinase (CK) Isoenzyme MBJHT · Traditional | Data Medical Associates, Inc. | 11/10/1988SE |
| K874284 | Shot-Gun Isolat Proced/Measurement Ck-Mb in SerumJHT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 01/21/1988SE |
| K872041 | Coulter Dart Ck-Mb Isoenzyme Reagent SystemJHT · Traditional | Coulter Electronics, Inc. | 09/16/1987SE |
More from Coulter Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was CPK - Isoenzymes cleared by the FDA?
CPK - Isoenzymes (K760028) received a 510(k) decision of Substantially Equivalent on September 15, 1976, 93 days after the submission was received.
What is the product code of K760028?
The FDA product code is JHT – Chromatographic Separation, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.