Nephelometer
FDA product code JZW · Class I (low risk) · 21 CFR 866.4540 · Immunology
11510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001647 | BN Prospec SystemJZW · Traditional | Dade Behring, Inc. | 09/26/2000SE |
| K761234 | Behring Laser NephelometerJZW · Traditional | Behring Diagnostics, Inc. | 06/07/1990SE |
| K892223 | Behring Nephelometer 100JZW · Traditional | Behring Diagnostics, Inc. | 05/04/1989SE |
| K873407 | RRT System Laser Reflectometer AnalyzerJZW · Traditional | Incstar Corp. | 09/23/1987SE |
| K873401 | TurboxJZW · Traditional | Unipath , Ltd. | 09/23/1987SE |
| K801949 | BCM-302 Collimating Cone & CompensatinJZW · Traditional | B C Medical , Ltd. | 10/03/1980SE |
| K801391 | Disc 120 TransporterJZW · Traditional | Travenol Laboratories, S.A. | 07/14/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | Sherwood Medical Industries | 11/13/1979SE |
| K781006 | Immunochemistry Sys. Manual ModeJZW · Traditional | Beckman Instruments, Inc. | 08/31/1978SE |
| K761236 | Antiserum Human (Pro.) Nephelometric Gr.JZW · Traditional | Behring Diagnostics, Inc. | 12/30/1976SE |
| K761235 | Laser Standard SerumJZW · Traditional | Behring Diagnostics, Inc. | 12/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2341-2019 Class II | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination…Iincreased (falsely elevated) Albumin results compared to expected results | Siemens Healthcare Diagnostics, Inc. | 06/27/2019Terminated |