Data / Medical devices / United States / Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc.: FDA-registered device maker in Mishawaka, IN, United States, 11 510(k) clearances
Siemens Healthcare Diagnostics, Inc. is registered with the FDA (registration 3009448641) in Mishawaka, IN, United States. It lists 19 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 17, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009448641
- Address
- 430 S Beiger St, Mishawaka, IN, United States, 46544
- Owner or operator
- SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- January 18, 2008
- Registered through
- 2026
- Brand names listed
- Atellica DCA HbA1c Dx Reagent Kit, Atellica Japan Enzymatic Creatinine (ECreJ) Pack, Atellica VTLi hs-cTnI Reagent Cartridge, Atlas Cal Kit, Atlas Clarity Calibrator, Atlas Negative Control, Atlas Positive Control, CLINITEK Atlas Carosel and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 17, 2014 | K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | KQO | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| July 5, 2002 | K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | JFY | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| November 12, 1999 | K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| September 27, 1996 | K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| July 5, 1996 | K960888 | CHEK-STIX U.T.I. SELF-TEST | JMT | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| May 5, 1995 | K951361 | DCA 2000 SYSTEM FOR HEMOGLOBIN A1C | LCP | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| October 31, 1994 | K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) | JJW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| August 19, 1993 | K932674 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM | KQO | Substantially Equivalent | Miles Inc., Dental Products | accessdata.fda.gov |
| May 11, 1993 | K931467 | CHEK-STIX CONTROL STRIPS FOR URINALYSIS | JJW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| September 5, 1991 | K911625 | AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM | LCP | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| August 25, 1977 | K771559 | HEMA-TEK II SLIDE STAINER | KPA | Substantially Equivalent | Miles Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Enzymatic Method, Creatinine
- All makers of Urinalysis Controls (Assayed And Unassayed)
- All makers of Hemoglobin A1c Test System
- All makers of Slide Stainer, Automated
- All makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Updated November 17, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.