Panels › Clinical Chemistry › Product code JIR · Class 1
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation 862.1645
0510(k)s in 12 months (38 all time)
4recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in JIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Bayer Corp. | 4 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 4 |
| Boehringer Mannheim Corp. | 3 | 0 |
| Diagnostic Chemicals , Ltd. | 3 | 0 |
| Biotrol, USA, Inc. | 2 | 0 |
| Exocell, Inc. | 2 | 0 |
| Healthy.Io, Ltd. | 2 | 0 |
| Teco Diagnostics | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin
REF: 11537225 Open, Classified |
JIR | None listed |
| May 6, 2026 | DFI Co., Ltd. One Step P in vitro diagnostic test
REF: 8194 Open, Classified |
JIR | None listed |
| Mar 2, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin (UAlb). Material Number: 11537225 Open, Classified |
JIR | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo Protein Test Open, Classified |
JIR | None listed |
| Sep 27, 2024 | Healgen Scientific Llc Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color Open, Classified |
JIR | K111999 |
| Sep 18, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers. Open, Classified |
JIR | None listed |
| Sep 18, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers Open, Classified |
JIR | None listed |
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