Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 667 FDA device recalls on record.
Clearances by Siemens Healthcare Diagnostics, Inc. — page 2
101–154 of 154- K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K131307 — ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
- K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K132739 — IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
- K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
- K133122 — IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
- K133124 — IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA
- K133128 — IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION
- K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
- K131662 — IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
- K132249 — ADVIA CENTAUR FT4, ADVIA CENTAUR T4
- K131536 — IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
- K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAY
- K130276 — DIMENSION EXL WITH LM SYSTEM
- K122534 — IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
- K123933 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
- K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
- K121994 — DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
- K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
- K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
- K120681 — ADVIA CHEMISTRY GLUH_3 REAGENTS
- K121084 — LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
- K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
- K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
- K112523 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K113373 — DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
- K110586 — ADVIA CENTAUR VITAMIN D TOTAL ASSAY
- K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD
- K111677 — MICROSCAN(R) MICROSTREP PLUS(R)
- K111205 — MICROSCAN (R) MICROSTREP PLUS (R) PANELS
- K111394 — MICROSCAN MICROSTEP
- K103548 — ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
- K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
- K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
- K093987 — IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
- K102779 — EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
- K103701 — ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
- K103836 — ENZYME II CALIBRATOR
- K103612 — DIMENSION VISA ENZ 2 CAL
- K090330 — DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
- K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
- K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
- K083373 — IMMULITE 2000 FREE T4
- K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
- K081789 — DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
- K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
- K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
- K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- K081319 — DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
- K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
- K081716 — ADVIA CENTAUR HAVM ASSAY
- K081074 — DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
- K081103 — LOCI THYROID CALIBRATOR WITH MODEL RC610
- K080578 — DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
Data sourced from openFDA. This site is unofficial and independent of the FDA.