PHOTIC-100 Spectrophotometer
FDA 510(k) K854679 · Future Impex Corp.
510(k) numberK854679
Submission
- Device name
- PHOTIC-100 Spectrophotometer
- Applicant
- Future Impex Corp.
Deerpark, NY, US - Received
- November 20, 1985
- Decision date
- February 20, 1986
- 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 |
|---|---|---|
| K861487 | ST-90 Spiro AnalizerBTY · Traditional | 06/23/1986SE |
| K854687 | Erma Hb-Meter Model 303NKHG · Traditional | 06/04/1986SE |
| K854686 | TE-25 Coaguro MeterJBP · Traditional | 06/04/1986SE |
| K854685 | DIGITAL-9 Key Leucocyte CounterGKM · Traditional | 04/04/1986SE |
| K854678 | Erma PC-602 PC-603 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854677 | Erma PC-604 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K843934 | Model {M-102 I-Channel Electro Cardiograph UnitDPS · Traditional | 11/20/1984SE |
| K843984 | PM-80 PulmotesterBZG · Traditional | 10/24/1984SE |
| K843700 | ST-200A W/Maximal Voluntary Ventillat- · Traditional | 10/24/1984SE |
| K832433 | Automatic Spirometer ST-200BZG · Traditional | 09/29/1983SE |
Questions and answers
When was PHOTIC-100 Spectrophotometer cleared by the FDA?
PHOTIC-100 Spectrophotometer (K854679) received a 510(k) decision of Substantially Equivalent on February 20, 1986, 92 days after the submission was received.
What is the product code of K854679?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.