ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
FDA 510(k) clearance K023105 · decided 2003-03-13
Clearance details
- K-number
- K023105
- Device name
- ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
- Applicant
- Elan Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2002-09-18
- Decision date
- 2003-03-13
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, 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 |
|---|
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (K130870) | Hitachi Chemical Diagnostics, Inc. | 2013-05-02 |
| DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (K083339) | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 |
| ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H (K070249) | Horiba Abx | 2007-04-26 |
| SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (K053401) | Arkray, Inc. | 2006-03-24 |
| SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (K050077) | Arkray, Inc. | 2005-02-15 |
| RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009) | Hemagen Diagnostics, Inc. | 2004-06-25 |
| WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (K013652) | Wiener Laboratories Saic | 2001-12-21 |
| RANDOX CALCIUM (K000375) | Randox Laboratories, Ltd. | 2000-04-05 |
| BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 (K991111) | A.P. Total Care, Inc. | 1999-05-25 |
| CALCIUM REAGENT (K971907) | Carolina Liquid Chemistries Corp. | 1997-06-24 |
| COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292) | Roche Diagnostic Systems, Inc. | 1996-10-31 |
| CALCIUM REAGENT (K955939) | Derma Media Lab., Inc. | 1996-03-13 |
Recalls involving this device
No recalls on record reference this clearance.