Biowhittaker Cartridge Software for EIA-400 Plate Reader
FDA 510(k) K942250 · Biowhittaker Molecular Applications, Inc.
510(k) numberK942250
Submission
- Device name
- Biowhittaker Cartridge Software for EIA-400 Plate Reader
- Applicant
- Biowhittaker Molecular Applications, Inc.
Walkersville, MD, US - Received
- May 9, 1994
- Decision date
- April 4, 1995
- 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
| 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 |
|---|---|---|
| K943843 | Varicelisa, ModificationLFY · Traditional | 03/14/1996SE |
| K942361 | WhitsoftJJQ · Traditional | 04/04/1995SE |
| K942245 | Biowhittaker 2001 Microplate Reader FirmwareJJQ · Traditional | 04/03/1995SE |
| K925209 | Mumps StatLJY · Traditional | 10/14/1994SE |
| K935618 | Specimen Transport MediumJSM · Traditional | 04/21/1994SE |
| K932679 | Rheumelisa II Histone Antibody Test KitLKJ · Traditional | 08/23/1993SE |
| K930757 | Rheumelisa II JO-1 Antibody Test KitLLL · Traditional | 03/26/1993SE |
| K930130 | Rheumelisa II SCL-70 Antibody Test KitLLL · Traditional | 03/23/1993SE |
| K920753 | RF Stat Igm Test KitDHR · Traditional | 03/30/1992SE |
Questions and answers
When was Biowhittaker Cartridge Software for EIA-400 Plate Reader cleared by the FDA?
Biowhittaker Cartridge Software for EIA-400 Plate Reader (K942250) received a 510(k) decision of Substantially Equivalent on April 4, 1995, 330 days after the submission was received.
What is the product code of K942250?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.