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Azo Dye, Calcium

Regulation 862.1145

0510(k)s in 12 months (47 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in CJY

Company510(k)sRecalls
Ortho-Clinical Diagnostics, Inc.23
Harleco40
Randox Laboratories, Ltd.22
Abbott Laboratories20
Data Medical Associates, Inc.20
Diagnostic Chemicals , Ltd.20
Hichem Diagnostics20
HORIBA ABX SAS20
Siemens Healthcare Diagnostics11
Sigma Diagnostics, Inc.20
DateFirm and productCodeLinked 510(k)
Aug 15, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Open, Classified		 CJYK072440
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Open, Classified		 CJYK072440
Feb 9, 2022Siemens Healthcare Diagnostics, Inc.
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Open, Classified		 CJYK083386
Dec 4, 2018Randox Laboratories Ltd.
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Terminated		 CJYK182042
Dec 4, 2018Randox Laboratories Ltd.
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Terminated		 CJYK974607
May 18, 2016Ortho-Clinical Diagnostics
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro
Terminated		 CJYK072440
Jan 14, 2014Vital Diagnostics, Inc.
Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
Terminated		 CJYK120626
Jan 14, 2014Vital Diagnostics, Inc.
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Terminated		 CJYK120626
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/3
Terminated		 CJYK072440
K961226
Nov 7, 2013SEPPIM SAS
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSEN
Terminated		 CJYK110830

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