Behring Laser Nephelometer
FDA 510(k) K761234 · Behring Diagnostics, Inc.
510(k) numberK761234
Submission
- Device name
- Behring Laser Nephelometer
- Applicant
- Behring Diagnostics, Inc.
San Jose, CA, US - Received
- June 7, 1990
- Decision date
- June 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZW – Nephelometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4540
- Specialty
- Immunology
Other 510(k)s with product code JZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001647 | BN Prospec SystemJZW · Traditional | Dade Behring, Inc. | 09/26/2000SE |
| 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 |
More from Behring Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was Behring Laser Nephelometer cleared by the FDA?
Behring Laser Nephelometer (K761234) received a 510(k) decision of Substantially Equivalent on June 7, 1990, 0 days after the submission was received.
What is the product code of K761234?
The FDA product code is JZW – Nephelometer, a Class I (low risk) device regulated under 21 CFR 866.4540.