BCM-302 Collimating Cone & Compensatin
FDA 510(k) K801949 · B C Medical , Ltd.
510(k) numberK801949
Submission
- Device name
- BCM-302 Collimating Cone & Compensatin
- Applicant
- B C Medical , Ltd.
Mchenry, IL, US - Received
- August 15, 1980
- Decision date
- October 3, 1980
- 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 |
| 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 |
| 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 |
|---|---|---|
| K946378 | BCM 400CPIZI · Traditional | 05/04/1995SE |
| K933100 | ARC-600JAA · Traditional | 11/08/1993SE |
| K933035 | BCM-600TXKPX · Traditional | 10/08/1993SE |
| K920862 | BCM-400CIZI · Traditional | 09/30/1992SE |
| K890306 | Bcm-Arc 105 X-Ray Mobile UnitIZL · Traditional | 04/17/1989SE |
| K870205 | Rotax-Ii Bi-Plane Circular Arm · Traditional | 03/06/1987SE |
| K801950 | BCM-600 Mini-Six Extra Lg. Field AngioKPX · Traditional | 10/03/1980SE |
Questions and answers
When was BCM-302 Collimating Cone & Compensatin cleared by the FDA?
BCM-302 Collimating Cone & Compensatin (K801949) received a 510(k) decision of Substantially Equivalent on October 3, 1980, 49 days after the submission was received.
What is the product code of K801949?
The FDA product code is JZW – Nephelometer, a Class I (low risk) device regulated under 21 CFR 866.4540.