ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
FDA 510(k) clearance K132571 · decided 2013-10-18
Clearance details
- K-number
- K132571
- Device name
- ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2013-08-15
- Decision date
- 2013-10-18
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- JHY
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dimension Vista MMB Assay (K143720) | Siemens Healthcare Diagnostics | 2015-09-18 |
| EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL (K130080) | Medica Corporation | 2014-05-13 |
| ELECSYS CK-MB STAT IMMUNOASSAY (K140404) | Roche Diagnostics | 2014-05-08 |
| OLYMPUS CK-MB REAGENT (K070835) | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 |
| SPIFE CK KIT, MODEL 3332, 3333 (K022757) | Helena Laboratories | 2002-10-11 |
| MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654) | Roche Diagnostics Corp. | 2002-08-29 |
| ELECSYS CK-MB STAT (K974421) | Boehringer Mannheim Corp. | 1997-12-17 |
| MMB METHOD (K970343) | Dade Chemistry Systems, Inc. | 1997-02-14 |
| CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412) | Bayer Corp. | 1996-06-18 |
| AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (K951638) | Organon Teknika Corp. | 1995-05-02 |
| IMX(R) STAT CK-MB (K931172) | Abbott Laboratories | 1993-06-15 |
| OPUS(R) CK-MB (K924429) | Pb Diagnostic Systems, Inc. | 1992-10-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |