Nephelometer, For Clinical Use
FDA product code JQX · Class I (low risk) · 21 CFR 862.2700 · Clinical Chemistry
14510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962294 | Immage Immunochemistry SystemJQX · Traditional | Beckman Instruments, Inc. | 08/21/1996SE |
| K922273 | Array(R) 360JQX · Traditional | Beckman Instruments, Inc. | 08/19/1992SE |
| K885263 | Qms(Tm) - TheophyllineJQX · Traditional | Seradyn, Inc. | 03/28/1989SE |
| K851253 | TDX Analyzer W/Nephelometry CarouselJQX · Traditional | Abbott Laboratories | 04/30/1985SE |
| K851234 | A-Just Turbidity MeterJQX · Traditional | Abbott Laboratories | 04/29/1985SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | J.T. Baker Chemical Co. | 07/21/1980SE |
| K801089 | J.T. Baker NephelometerJQX · Traditional | J.T. Baker Chemical Co. | 05/28/1980SE |
| K792045 | Biovation NephelometerJQX · Traditional | Biovation, Inc. | 10/30/1979SE |
| K790103 | Nephelometer, MIC-2000 LaserJQX · Traditional | Dynatech Corp. | 03/12/1979SE |
| K781554 | RAD-291JQX · Traditional | Organon, Inc. | 10/11/1978SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | Biovation, Inc. | 10/03/1978SE |
| K780251 | NephelometerJQX · Traditional | Kallestad Laboratories, Inc. | 04/06/1978SE |
| K772361 | Laser Immunonephelometric AnalyzerJQX · Traditional | G.D. Searle and Co. | 01/30/1978SE |
| K771446 | Transporteo ModuleJQX · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 08/10/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0198-2018 Class III | BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use…Potential unexpected movement of robot arm | Becton Dickinson & Co. | 06/01/2017Terminated |
| Z-2195-2010 | IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received… | Beckman Coulter Inc. | 05/21/2010Terminated |