Nephelometer, MIC-2000 Laser
FDA 510(k) K790103 · Dynatech Corp.
510(k) numberK790103
Submission
- Device name
- Nephelometer, MIC-2000 Laser
- Applicant
- Dynatech Corp.
Mchenry, IL, US - Received
- January 16, 1979
- Decision date
- March 12, 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 |
| K792045 | Biovation NephelometerJQX · Traditional | Biovation, Inc. | 10/30/1979SE |
| K781554 | RAD-291JQX · Traditional | Organon, Inc. | 10/11/1978SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | Biovation, Inc. | 10/03/1978SE |
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|---|---|---|
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| K854603 | Multi Mash 2000LIB · Traditional | 12/06/1985SE |
| K854602 | Mini Mash 2000LIB · Traditional | 12/06/1985SE |
| K832117 | Immulon Substrate Removawell StripsLIB · Traditional | 08/08/1983SE |
| K823787 | Handi-WashLIB · Traditional | 03/09/1983SE |
| K823833 | Micro Stix #011-010-5000 & HOLDER#5100LIB · Traditional | 03/08/1983SE |
| K830200 | Microelisa Minireader IILBI · Traditional | 02/16/1983SE |
| K823773 | Provial II #006-010-0201KDT · Traditional | 01/21/1983SE |
| K823557 | Removawell Plate LidLIB · Traditional | 12/28/1982SE |
Questions and answers
When was Nephelometer, MIC-2000 Laser cleared by the FDA?
Nephelometer, MIC-2000 Laser (K790103) received a 510(k) decision of Substantially Equivalent on March 12, 1979, 55 days after the submission was received.
What is the product code of K790103?
The FDA product code is JQX – Nephelometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2700.