Digene DML 2000 Microplate Luminometer
FDA 510(k) K980120 · Digene Corp.
510(k) numberK980120
Submission
- Device name
- Digene DML 2000 Microplate Luminometer
- Applicant
- Digene Corp.
Beltsville, MD, US - Received
- January 13, 1998
- Decision date
- February 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | Otsuka Pharmaceutical Co., Ltd. | 12/21/2001SE |
| 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 |
| K953005 | Bili-MeterJJQ · Traditional | Olympic Medical Corp. | 09/28/1995SE |
More from Olympic Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K010891 | Modification to Hybrid Capture II Ct/Gc Test, Model 03M90-01LSK · Traditional | 09/25/2001SE |
| K010893 | Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01LSL · Traditional | 09/24/2001SE |
| K010892 | Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01LSK · Traditional | 09/24/2001SE |
| K981567 | Hybrid Capture II Ct/Gc TestLSL · Traditional | 02/29/2000SE |
| K981485 | Hybrid Capture II Gc-IdLSL · Traditional | 11/29/1999SE |
| K990023 | Hybrid Capture II Ct-Id TestLSK · Traditional | 10/25/1999SE |
| K974901 | Hybrid Capture System CMV DNA AssayLJO · Traditional | 09/29/1998SE |
| K971586 | Digene Cervical BrushHHT · Traditional | 09/19/1997SE |
Questions and answers
When was Digene DML 2000 Microplate Luminometer cleared by the FDA?
Digene DML 2000 Microplate Luminometer (K980120) received a 510(k) decision of Substantially Equivalent on February 6, 1998, 24 days after the submission was received.
What is the product code of K980120?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.