510(k) Report

Devices descending from K991576

17 later devices reach Additional Assays for the Bayer Advia 1650 Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd.201701
+1K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)Randox Laboratories Limited20170—
+1K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.201602
+1K122323Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista…Siemens Healthcare Diagnostics201201
+1K121907Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase…Siemens Healthcare Diagnostics20120—
+1K083386Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…Siemens Healthcare Diagnostics200911
+1K073295Urea/Bun, Scal, Nortrol, AbtrolThermofisher Scientific OY20080—
+1K073612Uric Acid (Aox), Scal, Nortrol, AbtrolThermofisher Scientific OY20080—
+1K073355Calcium, Scal, Nortrol, AbtrolThermofisher Scientific OY20080—
+1K073191Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolThermofisher Scientific OY20080—
+1K070727Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics200745
+1K011963Advia 1650 Glucose Hexokinase 11 AssayBayer Corp.20010—
+2K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.20210—
+2K182042Randox Calcium (Ca)Randox Laboratories, Ltd.201801
+2K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.201621
+3K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.20241—
+4K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health20250—