BN Prospec System
FDA 510(k) K001647 · Dade Behring, Inc.
510(k) numberK001647
Submission
- Device name
- BN Prospec System
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- May 30, 2000
- Decision date
- September 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| K761234 | Behring Laser NephelometerJZW · Traditional | Behring Diagnostics, Inc. | 06/07/1990SE |
| 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 |
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Questions and answers
When was BN Prospec System cleared by the FDA?
BN Prospec System (K001647) received a 510(k) decision of Substantially Equivalent on September 26, 2000, 119 days after the submission was received.
What is the product code of K001647?
The FDA product code is JZW – Nephelometer, a Class I (low risk) device regulated under 21 CFR 866.4540.