JQX · Nephelometer, For Clinical Use
Clinical Chemistry · 21 CFR 862.2700 · Class 1
Overview
| Product Code | JQX |
|---|---|
| Device Name | Nephelometer, For Clinical Use |
| Regulation | 21 CFR 862.2700 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM | Beckman Instruments, Inc. | Aug 21, 1996 | SESE |
| K922273 | ARRAY(R) 360 | Beckman Instruments, Inc. | Aug 19, 1992 | SESE |
| K885263 | QMS(TM) - THEOPHYLLINE | Seradyn, Inc. | Mar 28, 1989 | SESE |
| K851253 | TDX ANALYZER W/NEPHELOMETRY CAROUSEL | Abbott Laboratories | Apr 30, 1985 | SESE |
| K851234 | A-JUST TURBIDITY METER | Abbott Laboratories | Apr 29, 1985 | SESE |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | Jul 21, 1980 | SESE |
| K801089 | J.T. BAKER NEPHELOMETER | J.T. Baker Chemical Co. | May 28, 1980 | SESE |
| K792045 | BIOVATION NEPHELOMETER | Biovation, Inc. | Oct 30, 1979 | SESE |
| K790103 | NEPHELOMETER, MIC-2000 LASER | Dynatech Corp. | Mar 12, 1979 | SESE |
| K781554 | RAD-291 | Organon, Inc. | Oct 11, 1978 | SESE |
| K781644 | ANTIBIOTIC NEPHELOMETER | Biovation, Inc. | Oct 3, 1978 | SESE |
| K780251 | NEPHELOMETER | Kallestad Laboratories, Inc. | Apr 6, 1978 | SESE |
| K772361 | LASER IMMUNONEPHELOMETRIC ANALYZER | G.D. Searle and Co. | Jan 30, 1978 | SESE |
| K771446 | TRANSPORTEO MODULE | Hyland Therapeutic Div., Travenol Laboratories | Aug 10, 1977 | SESE |
Top Applicants
- Abbott Laboratories — 2 clearances
- Beckman Instruments, Inc. — 2 clearances
- Biovation, Inc. — 2 clearances
- J.T. Baker Chemical Co. — 2 clearances
- Dynatech Corp. — 1 clearance
