Imack-Mb(Tm)
FDA 510(k) K872592 · Intl. Immunoassay Laboratories, Inc.
510(k) numberK872592
Submission
- Device name
- Imack-Mb(Tm)
- Applicant
- Intl. Immunoassay Laboratories, Inc.
Santa Clara, CA, US - Received
- July 1, 1987
- Decision date
- July 31, 1987
- 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 |
|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MBJHX · Traditional | 04/22/1992SE |
| K913349 | Stambi-CkJHW · Traditional | 10/23/1991SE |
| K912231 | Proposed New Use of Instrument System and Test KitJHW · Traditional | 07/08/1991SE |
| K903441 | Mydas(Tm) Brand Solid-Phase Antibody ReagentsJHX · Traditional | 11/06/1990SE |
| K903508 | Labelling Changes to Impres-Mb-XJHW · Traditional | 09/07/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | 05/15/1990SE |
| K890609 | Impres-Mb (Addition of an Optional Test Procedure)CGS · Traditional | 03/16/1989SE |
| K890543 | Impres-Mb Reagent a and Reagent BJHX · Traditional | 03/13/1989SE |
| K883432 | Immunoccult-LxiKHE · Traditional | 10/31/1988SE |
| K883223 | Check-MmJHS · Traditional | 09/30/1988SE |
Questions and answers
When was Imack-Mb(Tm) cleared by the FDA?
Imack-Mb(Tm) (K872592) received a 510(k) decision of Substantially Equivalent on July 31, 1987, 30 days after the submission was received.
What is the product code of K872592?
The FDA product code is JHT – Chromatographic Separation, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.