Lumicon
FDA 510(k) K873893 · Hamilton Co.
510(k) numberK873893
Submission
- Device name
- Lumicon
- Applicant
- Hamilton Co.
Reno, NV, US - Received
- September 23, 1987
- Decision date
- January 5, 1988
- 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 |
|---|---|---|
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | 08/16/1996SE |
| K943493 | Discrete Photometric Chemistry AnalyzerJJE · Traditional | 01/30/1995SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | 06/02/1989SE |
| K871945 | Microlab atJTC · Traditional | 05/29/1987SE |
| K832205 | Precision Liquid DispenserJQW · Traditional | 08/24/1983SE |
| K832204 | Microlab PJQW · Traditional | 08/24/1983SE |
| K832202 | PB 600 Repeating DispenserJQW · Traditional | 08/24/1983SE |
| K832201 | Chrom-PrepKZR · Traditional | 08/16/1983SE |
| K832200 | PRP-1 Reversed Phase Columns for HPLCDPM · Traditional | 08/16/1983SE |
| K832199 | HC40/HC75 Cation Exchange ResinDNH · Traditional | 08/16/1983SE |
Questions and answers
When was Lumicon cleared by the FDA?
Lumicon (K873893) received a 510(k) decision of Substantially Equivalent on January 5, 1988, 104 days after the submission was received.
What is the product code of K873893?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.