Cbi 7520 Reader
FDA 510(k) K961183 · Columbia Bioscience, Inc.
510(k) numberK961183
Submission
- Device name
- Cbi 7520 Reader
- Applicant
- Columbia Bioscience, Inc.
Frederick, MD, US - Received
- March 26, 1996
- Decision date
- August 2, 1996
- 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
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| 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 |
| 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 |
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| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | 12/07/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982350 | Ea-D Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
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Questions and answers
When was Cbi 7520 Reader cleared by the FDA?
Cbi 7520 Reader (K961183) received a 510(k) decision of Substantially Equivalent on August 2, 1996, 129 days after the submission was received.
What is the product code of K961183?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.