RRT System Laser Reflectometer Analyzer
FDA 510(k) K873407 · Incstar Corp.
510(k) numberK873407
Submission
- Device name
- RRT System Laser Reflectometer Analyzer
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- August 25, 1987
- Decision date
- September 23, 1987
- 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 |
| 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 |
|---|---|---|
| K963289 | Incstar Toxoplasma Igm Capture Elisa AssayLGD · Traditional | 05/01/1997SE |
| K963297 | Incstar Toxoplasma Igg Fast Elisa Assay (CAT.#7560)LGD · Traditional | 12/16/1996SE |
| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was RRT System Laser Reflectometer Analyzer cleared by the FDA?
RRT System Laser Reflectometer Analyzer (K873407) received a 510(k) decision of Substantially Equivalent on September 23, 1987, 29 days after the submission was received.
What is the product code of K873407?
The FDA product code is JZW – Nephelometer, a Class I (low risk) device regulated under 21 CFR 866.4540.