Biovation Nephelometer
FDA 510(k) K792045 · Biovation, Inc.
510(k) numberK792045
Submission
- Device name
- Biovation Nephelometer
- Applicant
- Biovation, Inc.
Mchenry, IL, US - Received
- October 12, 1979
- Decision date
- October 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQX – Nephelometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2700
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962294 | Immage Immunochemistry SystemJQX · Traditional | Beckman Instruments, Inc. | 08/21/1996SE |
| K922273 | Array(R) 360JQX · Traditional | Beckman Instruments, Inc. | 08/19/1992SE |
| K885263 | Qms(Tm) - TheophyllineJQX · Traditional | Seradyn, Inc. | 03/28/1989SE |
| K851253 | TDX Analyzer W/Nephelometry CarouselJQX · Traditional | Abbott Laboratories | 04/30/1985SE |
| K851234 | A-Just Turbidity MeterJQX · Traditional | Abbott Laboratories | 04/29/1985SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | J.T. Baker Chemical Co. | 07/21/1980SE |
| K801089 | J.T. Baker NephelometerJQX · Traditional | J.T. Baker Chemical Co. | 05/28/1980SE |
| K790103 | Nephelometer, MIC-2000 LaserJQX · Traditional | Dynatech Corp. | 03/12/1979SE |
| K781554 | RAD-291JQX · Traditional | Organon, Inc. | 10/11/1978SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | Biovation, Inc. | 10/03/1978SE |
More from Biovation, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925528 | Biovation K-ManagerGKZ · Traditional | 02/05/1993SE |
| K923844 | Lyris 100/120 Laboratory Information SystemJJQ · Traditional | 12/11/1992SE |
| K915071 | Differential Counting BoardGKZ · Traditional | 01/17/1992SE |
| K853026 | Biovation Max Data Management SystemJQP · Traditional | 08/02/1985SE |
| K842401 | Chemistry ConsoleJQP · Traditional | 09/04/1984SE |
| K831830 | Lyris Modular Info SystemJQP · Traditional | 06/25/1984SE |
| K821534 | Hematology Data Management SysJGP · Traditional | 06/10/1982SE |
| K812604 | Biovation Urinalysis ReporterJQP · Traditional | 10/02/1981SE |
| K790862 | Biovation Digital UrinometerJRE · Traditional | 06/28/1979SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | 10/03/1978SE |
Questions and answers
When was Biovation Nephelometer cleared by the FDA?
Biovation Nephelometer (K792045) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 18 days after the submission was received.
What is the product code of K792045?
The FDA product code is JQX – Nephelometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2700.