Nephelometer
A nephelometer is a laboratory instrument used to measure the turbidity or light-scattering properties of a solution, commonly employed in immunology testing to quantify proteins, antibodies, and other analytes in serum or other body fluids. It is regulated as an FDA Class 1 device, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing standards, with no requirement for premarket notification. The product code is JZW, regulated under 21 CFR 866.4540, within the Immunology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JZW
- Device Class
- FDA class 1
- Regulation Number
- 866.4540
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K001647 | BN PROSPEC SYSTEM | Sep 26, 2000 | Substantially Equivalent | Dade Behring, Inc. |
| K761234 | BEHRING LASER NEPHELOMETER | Jun 07, 1990 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K892223 | BEHRING NEPHELOMETER 100 | May 04, 1989 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K873407 | RRT SYSTEM LASER REFLECTOMETER ANALYZER | Sep 23, 1987 | Substantially Equivalent | Incstar Corp. |
| K873401 | TURBOX | Sep 23, 1987 | Substantially Equivalent | Unipath , Ltd. |
| K801949 | BCM-302 COLLIMATING CONE & COMPENSATIN | Oct 03, 1980 | Substantially Equivalent | B C Medical , Ltd. |
| K801391 | DISC 120 TRANSPORTER | Jul 14, 1980 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent | Sherwood Medical Industries |
| K781006 | IMMUNOCHEMISTRY SYS. MANUAL MODE | Aug 31, 1978 | Substantially Equivalent | Beckman Instruments, Inc. |
| K761236 | ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. | Dec 30, 1976 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K761235 | LASER STANDARD SERUM | Dec 30, 1976 | Substantially Equivalent | Behring Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.