Dynatech MR4000 Microplate Reader
FDA 510(k) K904567 · Dynatech Corp.
510(k) numberK904567
Submission
- Device name
- Dynatech MR4000 Microplate Reader
- Applicant
- Dynatech Corp.
Chantilly, VA, US - Received
- October 9, 1990
- Decision date
- January 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2300
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | Otsuka Pharmaceutical Co., Ltd. | 12/21/2001SE |
| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | Digene Corp. | 02/06/1998SE |
| K973938 | Alpha 4 LS Automated Microtiterplate Processor and ReaderJJQ · Traditional | Sfri, Inc. | 02/04/1998SE |
| K974762 | Stat TracksJJQ · Traditional | Awareness Technology, Inc. | 01/28/1998SE |
| K962113 | Anthos Phacts Version Microplate ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 11/05/1996SE |
| K961183 | Cbi 7520 ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 08/02/1996SE |
| K962166 | Origen AnalyzerJJQ · Traditional | Igen, Inc. | 07/31/1996SE |
| K955077 | Anthos 2010 ReaderJJQ · Traditional | Anthos Labtec, Inc. | 12/04/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/19/1995SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K854604 | Auto MashLIB · Traditional | 12/06/1985SE |
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| 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 |
| K822962 | Microfluor B Removawell StripsLIB · Traditional | 11/16/1982SE |
Questions and answers
When was Dynatech MR4000 Microplate Reader cleared by the FDA?
Dynatech MR4000 Microplate Reader (K904567) received a 510(k) decision of Substantially Equivalent on January 28, 1991, 111 days after the submission was received.
What is the product code of K904567?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.