Imack-Mb, Catalogs 602-1, 602-1/125, 602-1/225
FDA 510(k) K881351 · Intl. Immunoassay Laboratories, Inc.
510(k) numberK881351
Submission
- Device name
- Imack-Mb, Catalogs 602-1, 602-1/125, 602-1/225
- Applicant
- Intl. Immunoassay Laboratories, Inc.
Santa Clara, CA, US - Received
- March 30, 1988
- Decision date
- June 1, 1988
- 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
Other 510(k)s with product code JHY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143720 | Dimension Vista MMB AssayJHY · Traditional | Siemens Healthcare Diagnostics | 09/18/2015SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | Medica Corporation | 05/13/2014SE |
| K140404 | Elecsys Ck-Mb Stat ImmunoassayJHY · Special | Roche Diagnostics | 05/08/2014SE |
| K132571 | Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional | Roche Diagnostics | 10/18/2013SE |
| K070835 | Olympus Ck-Mb ReagentJHY · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/04/2007SE |
| 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 |
More from Bayer Corp.
| 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, Catalogs 602-1, 602-1/125, 602-1/225 cleared by the FDA?
Imack-Mb, Catalogs 602-1, 602-1/125, 602-1/225 (K881351) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 63 days after the submission was received.
What is the product code of K881351?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.