IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
FDA 510(k) clearance K003597 · decided 2001-02-05
Clearance details
- K-number
- K003597
- Device name
- IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-21
- Decision date
- 2001-02-05
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- LPS
- Device class
- 2
- Regulation number
- 862.1377
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, 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 |
|---|
| VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III (K123930) | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 |
| DIAZYME HOMOCYSTEINE POC TEST KIT (K121053) | Diazyme Laboratories | 2012-07-31 |
| ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET (K121533) | Tosoh Bioscience, Inc. | 2012-06-15 |
| HOMOCYSTEINE TEST (K113793) | Roche | 2012-06-05 |
| AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (K112790) | Axis-Shield Diagnostics, Ltd. | 2012-05-07 |
| AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (K083222) | Axis-Shield Diagnostics, Ltd. | 2009-07-31 |
| A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (K080851) | Anticancer, Inc. | 2008-10-10 |
| ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (K073640) | Axis-Shield Diagnostics, Ltd. | 2008-04-24 |
| DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL (K071971) | Diazyme Laboratories | 2007-09-17 |
| TECO HOMOCYSTEINE ENZYMATIC ASSAY (K063701) | Teco Diagnostics | 2007-04-11 |
| DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH (K063206) | Dade Behring, Inc. | 2006-12-28 |
| LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT (K062808) | Catch Incorporated | 2006-10-13 |
Recalls involving this device
No recalls on record reference this clearance.