510(k) K061296
- Device
- DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K061296
- Product code
- LPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-13
- Date received
- 2006-05-09
- Regulation
- 862.1377
- Classification name
- Urinary Homocystine (nonquantitative) Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROLAND STRICKLAND
- Address
- 3550 General Atomics Ct. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3006198300
- 2030861
- 9610806
- 3005333358
- 2432235
- 3012963943
- 2250051
- 1217183
- 1319808
- 3002809144
- 9612316
- 8032314
- 1036362
- 1827821
- 8031673
- 9610746
- 3004493545
- 3033967997
- 3002642396
- 3037000637
- 2032900
- 8020888
- 1219913
- 3005529799
- 9610126
- 1319681
- 3000308930
- 3002806944
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LPS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | Diazyme Laboratories | 2012-07-31 |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | Tosoh Bioscience, Inc. | 2012-06-15 |
| K113793 | HOMOCYSTEINE TEST | Roche | 2012-06-05 |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | Axis-Shield Diagnostics, Ltd. | 2012-05-07 |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | Axis-Shield Diagnostics, Ltd. | 2009-07-31 |
| K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2008-10-10 |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | 2008-04-24 |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | Diazyme Laboratories | 2007-09-17 |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Teco Diagnostics | 2007-04-11 |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | 2006-12-28 |
| K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | Catch Incorporated | 2006-10-13 |
| K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | Instrumentation Laboratory CO | 2006-09-22 |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2006-07-21 |
| K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | Dade Behring, Inc. | 2006-03-29 |
Legacy Summary#
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FDA Review#
Decision Summary