Microlite ML 1000 (Model 3) Microplate Luminometer
FDA 510(k) K895313 · Dynatech Laboratories, Inc.
510(k) numberK895313
Submission
- Device name
- Microlite ML 1000 (Model 3) Microplate Luminometer
- Applicant
- Dynatech Laboratories, Inc.
Chantilly, VA, US - Received
- August 29, 1989
- Decision date
- October 17, 1989
- 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 |
More from Bio-Tek Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | 07/25/1996SE |
| K934111 | MR7000 with Time Manager Software (TMS)JQP · Traditional | 11/02/1994SE |
| K943701 | MRX Microplate ReaderJJQ · Traditional | 10/20/1994SE |
| K923456 | Microlite Microtiter Plate Luminometer ML3000JJQ · Traditional | 10/13/1992SE |
| K915896 | Microlite Microtiter Plate Luminometer ML2250/MODIJJQ · Traditional | 05/04/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | 03/19/1992SE |
| K913590 | Microlite ML 1000 Microtiter Plate LuminometerJJQ · Traditional | 10/25/1991SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | 10/17/1989SE |
| K894687 | Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional | 08/31/1989SE |
| K890502 | Microlite Tube Luminometer #011-902-0000JJQ · Traditional | 02/27/1989SE |
Questions and answers
When was Microlite ML 1000 (Model 3) Microplate Luminometer cleared by the FDA?
Microlite ML 1000 (Model 3) Microplate Luminometer (K895313) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 49 days after the submission was received.
What is the product code of K895313?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.