510(k) K912766
- Device
- AMERLITE CK-MB ASSAY
- Applicant
- AMERSHAM CORP.
- 510(k) number
- K912766
- Product code
- JHY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-17
- Date received
- 1991-06-24
- Regulation
- 862.1215
- Classification name
- Colorimetric Method, Cpk Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHRYN PATTERSON
- Address
- 2636 S. Clearbrook Dr. Arlington Heights IL US 60005 60005
FDA Registration Numbers#
- 1319436
- 1832216
- 3010825766
- 2517506
- 2020726
- 1220972
- 8023024
- 9610126
- 1618982
- 3006198300
- 9680746
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | 2015-09-18 |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | Medica Corporation | 2014-05-13 |
| K140404 | ELECSYS CK-MB STAT IMMUNOASSAY | Roche Diagnostics | 2014-05-08 |
| K132571 | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY | Roche Diagnostics | 2013-10-18 |
| K070835 | OLYMPUS CK-MB REAGENT | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Helena Laboratories | 2002-10-11 |
| K022654 | MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB | Roche Diagnostics Corp. | 2002-08-29 |
| K974421 | ELECSYS CK-MB STAT | Boehringer Mannheim Corp. | 1997-12-17 |
| K970343 | MMB METHOD | Dade Chemistry Systems, Inc. | 1997-02-14 |
| K961412 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO | Bayer Corp. | 1996-06-18 |
| K951638 | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK | Organon Teknika Corp. | 1995-05-02 |
| K931172 | IMX(R) STAT CK-MB | Abbott Laboratories | 1993-06-15 |
| K924429 | OPUS(R) CK-MB | Pb Diagnostic Systems, Inc. | 1992-10-15 |
| K922700 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. | E.I. Dupont DE Nemours & Co., Inc. | 1992-08-20 |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1992-06-09 |
Legacy Summary#
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FDA Review#
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