510(k) K122599
- Device
- ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
- Applicant
- Siemens Healthcare Diagnostics Inc.
- 510(k) number
- K122599
- Product code
- DDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-03
- Date received
- 2012-08-27
- Regulation
- 866.5680
- Classification name
- Myoglobin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIRA GORDON
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 3013982035
- 3006198300
- 2246703
- 3003795116
- 1181121
- 9610806
- 9680746
- 3014353045
- 3005174594
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 3004205692
- 3008344661
- 3002809144
- 9612316
- 1036362
- 2517506
- 2122870
- 8031673
- 3002637618
- 9610987
- 3019906
- 3004493545
- 3033967997
- 3002642396
- 3010825766
- 2032900
- 3029973107
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 3003366417
- 1319681
- 2435505
- 3000308930
- 3002806944
- 3000148879
- 2032839
Source Documents#
Other 510(k) Records For Product Code DDR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231832 | Access Myoglobin | Beckman Coulter, Inc. | 2023-09-18 |
| K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | 2013-06-07 |
| K083260 | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | Roche Diagnostics | 2009-10-16 |
| K080481 | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | Beckman Coulter, Inc. | 2009-02-20 |
| K061683 | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2006-07-21 |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | Fisher Diagnostics | 2005-01-24 |
| K042982 | QUANTEX MYOGLOBIN | Instrumentation Laboratory CO | 2004-12-22 |
| K033300 | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2003-11-05 |
| K021229 | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 | Beckman Coulter, Inc. | 2002-06-28 |
| K012040 | RAMP MYOGLOBIN ASSAY | Response Biomedical Corp. | 2001-12-18 |
| K010700 | RANDOX MYOGLOBIN | Randox Laboratories, Ltd. | 2001-05-08 |
| K000196 | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 | Beckman Coulter, Inc. | 2000-02-18 |
| K992976 | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | Kamiya Biomedical Co. | 1999-11-01 |
| K991796 | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 | Diagnostic Products Corp. | 1999-06-09 |
| K991277 | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 | Diagnostic Products Corp. | 1999-04-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary