Panels › Clinical Chemistry › Product code JIL · Class 2
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation 862.1340
0510(k)s in 12 months (81 all time)
1recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in JIL
| Company | 510(k)s | Recalls |
|---|---|---|
| Syn-Kit, Inc. | 11 | 0 |
| Tanabe U.S.A., Inc. | 8 | 0 |
| Teco Diagnostics | 8 | 0 |
| Kyoto Diagnostics, Inc. | 4 | 0 |
| Siemens Healthcare Diagnostics | 1 | 3 |
| Analyticon Biotechnologies AG | 3 | 0 |
| Arkray, Inc. | 3 | 0 |
| DFI Co., Ltd. | 3 | 0 |
| Macherey-Nagel GmbH & Co. KG | 2 | 1 |
| Miles Laboratories, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Diabetes Test (ketones & glucose) Open, Classified |
JIL | None listed |
| May 16, 2024 | Macherey Nagel Gmbh & Co. Kg Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique. Open, Classified |
JIL | K991927 |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. URISYS 2400 Urine Analyzer
Automated Urinalysis System
Product Usage:
The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection Terminated |
JIL | K012397 |
| Dec 8, 2014 | Beckman Coulter Inc. iChem 10 SG Urine Chemistry Strips, PN 800-7005.
Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, Terminated |
JIL | K060280 |
| Oct 17, 2014 | Siemens Healthcare Diagnostics, Inc External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part
The Clinitek Status system is a urine analyzer. Terminated |
JIL | K091216 |
| Oct 17, 2014 | Siemens Healthcare Diagnostics, Inc External power supply adaptors that accompany Clinitek Status Connect System
The Clinitek Status system is a urine analyzer. Terminated |
JIL | K091216 |
| Oct 17, 2014 | Siemens Healthcare Diagnostics, Inc External power supply adaptors that accompany Clinitek Status+
The Clinitek Status systems is a urine analyzer. Terminated |
JIL | K091216 |
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