Biotrack PDS Monitor
FDA 510(k) K895102 · Biotrack, Inc.
510(k) numberK895102
Submission
- Device name
- Biotrack PDS Monitor
- Applicant
- Biotrack, Inc.
Mountain View, CA, US - Received
- August 15, 1989
- Decision date
- October 10, 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 |
|---|---|---|
| K934062 | Biotrack Therapeutic Drug-Monitoring Qual ControlsDIF · Traditional | 12/29/1993SE |
| K934061 | Biotrack Valproic Acid Test CartridgeLEG · Traditional | 12/29/1993SE |
| K920525 | Biotrack Therapeutic Drug Monitoring Qual. ControlDIS · Traditional | 08/05/1992SE |
| K915756 | Biotrack Carbamazepine Test CartridgeKLT · Traditional | 07/23/1992SE |
| K915755 | Biotrack Phenytoin Test CartridgeDIP · Traditional | 07/23/1992SE |
| K903924 | Biotrack Theophylline Quality ControlsLAW · Traditional | 09/17/1990SE |
| K900373 | Biotrack Theophylline Test CartridgeKLS · Traditional | 05/30/1990SE |
| K900372 | Biotrack Immunochemistry MonitorJJQ · Traditional | 02/23/1990SE |
| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | 10/10/1989SE |
| K895128 | Biotrack Alt Test CartridgeCJJ · Traditional | 10/06/1989SE |
Questions and answers
When was Biotrack PDS Monitor cleared by the FDA?
Biotrack PDS Monitor (K895102) received a 510(k) decision of Substantially Equivalent on October 10, 1989, 56 days after the submission was received.
What is the product code of K895102?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.