MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
FDA 510(k) clearance K022654 · decided 2002-08-29
Clearance details
- K-number
- K022654
- Device name
- MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-09
- Decision date
- 2002-08-29
- Days to decision
- 20 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571) | Roche Diagnostics | 2013-10-18 |
| 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 |
| 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 FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |