IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
FDA 510(k) clearance K983970 · decided 1998-11-25
Clearance details
- K-number
- K983970
- Device name
- IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-09
- Decision date
- 1998-11-25
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DDR
- Device class
- 2
- Regulation number
- 866.5680
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Access Myoglobin (K231832) | Beckman Coulter, Inc. | 2023-09-18 |
| DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (K123785) | Diazyme Laboratories | 2013-06-07 |
| ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (K122599) | Siemens Healthcare Diagnostics, Inc. | 2012-10-03 |
| ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260) | Roche Diagnostics | 2009-10-16 |
| ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS (K080481) | Beckman Coulter, Inc. | 2009-02-20 |
| TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683) | Roche Diagnostics Corp. | 2006-07-21 |
| ARCHITECT STAT MYO IMMUNOASSAY (K042924) | Fisher Diagnostics | 2005-01-24 |
| QUANTEX MYOGLOBIN (K042982) | Instrumentation Laboratory CO | 2004-12-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS (K033300) | Ortho-Clinical Diagnostics, Inc. | 2003-11-05 |
| MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229) | Beckman Coulter, Inc. | 2002-06-28 |
| RAMP MYOGLOBIN ASSAY (K012040) | Response Biomedical Corp. | 2001-12-18 |
| RANDOX MYOGLOBIN (K010700) | Randox Laboratories, Ltd. | 2001-05-08 |
Recalls involving this device
No recalls on record reference this clearance.