510(k) K053401
- Device
- SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
- Applicant
- ARKRAY, INC.
- 510(k) number
- K053401
- Product code
- CIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-24
- Date received
- 2005-12-06
- Regulation
- 862.1145
- Classification name
- Cresolphthalein Complexone, Calcium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELEN LANDICHO
- Address
- 510 Furnace Dock Rd. Cortlandt Manor NY US 10567 10567
FDA Registration Numbers#
- 3013660430
- 3006198300
- 3003795116
- 1181121
- 2432235
- 9610529
- 1832216
- 8040374
- 1181055
- 2517506
- 1827821
- 3004493545
- 3010825766
- 3000148879
- 2085064
- 1616487
- 9610126
- 3021841051
- 3003593973
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
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| K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | Horiba Abx | 2007-04-26 |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | Arkray, Inc. | 2005-02-15 |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | 2004-06-25 |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | 2003-03-13 |
| K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Wiener Laboratories Saic | 2001-12-21 |
| K000375 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 2000-04-05 |
| K991111 | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 | A.P. Total Care, Inc. | 1999-05-25 |
| K971907 | CALCIUM REAGENT | Carolina Liquid Chemistries Corp. | 1997-06-24 |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1996-10-31 |
| K955939 | CALCIUM REAGENT | Derma Media Lab., Inc. | 1996-03-13 |
| K944258 | CALCIUM REAGENT | Olympus America, Inc. | 1995-01-05 |
| K931362 | IL TEST CALCIUM | Instrumentation Laboratory CO | 1994-02-01 |
| K932158 | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | 1993-09-27 |
Legacy Summary#
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FDA Review#
Decision Summary