Diagnostic Chemicals, Ltd.

CanadaFDA applicant, unverified

Devices: 66
FDA recalls: 6

Catalogue66

Newest first, rows 51-66 of 66

Search and filter all 66 devices

Y-Glutamyltransferase Assay, Catalogue Number 308-05 Ref K945800

Active Regimes: 510(k) Registry: 510(k) Class:I
Dc-Aceta/Sal Controls Ref K041666

Active Regimes: 510(k) Registry: 510(k) Class:I
Magnesium Assay (Xb), Models 125-12, 125-50 And 125-S7 Ref K063208

Active Regimes: 510(k) Registry: 510(k) Class:I
Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30 Ref K974003

Active Regimes: 510(k) Registry: 510(k) Class:I
Dc-Uibc-CO2-Cal, Model Se-153 Ref K013178

Active Regimes: 510(k) Registry: 510(k) Class:II
Ammonia-L3K Assay, Model 263-17, Ammonia-L3K Assay, Model 263-30 Ref K001285

Active Regimes: 510(k) Registry: 510(k) Class:I
Bilirubin-Sl (Total) Assay, Model 284-10/30 Ref K023330

Active Regimes: 510(k) Registry: 510(k) Class:II
Glucose-Sl-C Assay, Model 257-30 Ref K023739

Active Regimes: 510(k) Registry: 510(k) Class:II
Catalogue Number 321-07/15/50 Ref K945243

Active Regimes: 510(k) Registry: 510(k) Class:II
Acetaminophen-Sl Assay, Catalogue # 505-10, 505-30. Ref K981059

Active Regimes: 510(k) Registry: 510(k) Class:II
Crp-Advance Multi Calibrator Set, Model Se-250 Ref K060140

Active Regimes: 510(k) Registry: 510(k) Class:II
Crp-Advance Assay, Models 250-20, 250-25 Ref K060139

Active Regimes: 510(k) Registry: 510(k) Class:II
Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30 Ref K974859

Active Regimes: 510(k) Registry: 510(k) Class:II
Cholinesterase Assay Kit, Catalogue# 300-05 Ref K955498

Active Regimes: 510(k) Registry: 510(k) Class:I
Salicylate-Sl Assay Catalogue Number 511-20, 511-40 Ref K981872

Active Regimes: 510(k) Registry: 510(k) Class:II
Creatinine-S Assay, Model 221-30, 221-50, 221-17 Ref K000055

Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 51-66 of 66

Showing 51-66 of 66

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

2010
- 10 Nov 2010 Z-0711-2011 Unclassified (pre-2012) Terminated Cholesterol Reagent bottles labels reversed for R1 and R2 Distribution: Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada. Submission number: K842160
2009
- 12 Feb 2009 Z-2326-2009 Unclassified (pre-2012) Terminated Labeled with extended expiration date (24 months instead of 18 months) Distribution: Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea. Submission number: K070383
- 12 Feb 2009 Z-2327-2009 Unclassified (pre-2012) Terminated Labeled with extended expiration date (24 months instead of 18 months) Distribution: Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea. Submission number: K070383
2008
- 14 Mar 2008 Z-1327-2009 Unclassified (pre-2012) Terminated Precipitate in product may cause elevated background absorbance interference. Distribution: Nationwide Distribution Submission number: K961587
2006
- 5 Dec 2006 Z-0361-2007 Unclassified (pre-2012) Terminated Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories Distribution: PA Submission number: K042329
- 6 Sep 2006 Z-0536-2007 Unclassified (pre-2012) Terminated Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct Distribution: Nationwide. Submission number: K042243

Catalogue66

Y-Glutamyltransferase Assay, Catalogue Number 308-05 Ref K945800

Dc-Aceta/Sal Controls Ref K041666

Magnesium Assay (Xb), Models 125-12, 125-50 And 125-S7 Ref K063208

Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30 Ref K974003

Dc-Uibc-CO2-Cal, Model Se-153 Ref K013178

Ammonia-L3K Assay, Model 263-17, Ammonia-L3K Assay, Model 263-30 Ref K001285

Bilirubin-Sl (Total) Assay, Model 284-10/30 Ref K023330

Glucose-Sl-C Assay, Model 257-30 Ref K023739

Catalogue Number 321-07/15/50 Ref K945243

Acetaminophen-Sl Assay, Catalogue # 505-10, 505-30. Ref K981059

Crp-Advance Multi Calibrator Set, Model Se-250 Ref K060140

Crp-Advance Assay, Models 250-20, 250-25 Ref K060139

Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30 Ref K974859

Cholinesterase Assay Kit, Catalogue# 300-05 Ref K955498

Salicylate-Sl Assay Catalogue Number 511-20, 511-40 Ref K981872

Creatinine-S Assay, Model 221-30, 221-50, 221-17 Ref K000055

FDA recalls6