Product code JQX
- Device name
- Nephelometer, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2700
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM | Beckman Instruments, Inc. | 1996-08-21 |
| K922273 | ARRAY(R) 360 | Beckman Instruments, Inc. | 1992-08-19 |
| K885263 | QMS(TM) - THEOPHYLLINE | Seradyn, Inc. | 1989-03-28 |
| K851253 | TDX ANALYZER W/NEPHELOMETRY CAROUSEL | Abbott Laboratories | 1985-04-30 |
| K851234 | A-JUST TURBIDITY METER | Abbott Laboratories | 1985-04-29 |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-07-21 |
| K801089 | J.T. BAKER NEPHELOMETER | J.T. Baker Chemical Co. | 1980-05-28 |
| K792045 | BIOVATION NEPHELOMETER | Biovation, Inc. | 1979-10-30 |
| K790103 | NEPHELOMETER, MIC-2000 LASER | Dynatech Corp. | 1979-03-12 |
| K781554 | RAD-291 | Organon, Inc. | 1978-10-11 |
| K781644 | ANTIBIOTIC NEPHELOMETER | Biovation, Inc. | 1978-10-03 |
| K780251 | NEPHELOMETER | Kallestad Laboratories, Inc. | 1978-04-06 |
| K772361 | LASER IMMUNONEPHELOMETRIC ANALYZER | G.D. Searle and Co. | 1978-01-30 |
| K771446 | TRANSPORTEO MODULE | Hyland Therapeutic Div., Travenol Laboratories | 1977-08-10 |
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|---|---|---|---|
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| 05032384474516 | SENSITITRE NEPHELOMETER | TREK DIAGNOSTIC SYSTEMS LIMITED | 2022-12-14 |
| 15099590265403 | IMMAGE | Beckman Coulter, Inc. | 2020-08-24 |
| 00382902450153 | BD BBL™ CrystalSpec™ Calibration Tubes | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904409104 | BD PhoenixSpec™ Nephelometer | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904409111 | BD PhoenixSpec™ Calibrator Kit | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
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| 00382904413569 | BD PhoenixSpec™ Calibrator 0.50 McFarland | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
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| 00382904419530 | BD PhoenixSpec™ Calibrator 2.0 McFarland | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904480103 | BD Phoenix™ AP | BECTON, DICKINSON AND COMPANY | 2018-05-25 |