Stat FAX(TM)-2100
FDA 510(k) K900224 · Awareness Technology, Inc.
510(k) numberK900224
Submission
- Device name
- Stat FAX(TM)-2100
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- January 17, 1990
- Decision date
- March 1, 1990
- 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 |
|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS · Traditional | 02/27/2018SE |
| K013420 | Chemwell, Also Known AS Project 2900JLW · Abbreviated | 07/19/2002SE |
| K010877 | Chemwell, Model 2900CIX · Abbreviated | 05/23/2001SE |
| K974762 | Stat TracksJJQ · Traditional | 01/28/1998SE |
| K943729 | Dye Check Strips 545-630JJY · Traditional | 12/29/1994SE |
| K941394 | Stat Fax 2600JQW · Traditional | 06/03/1994SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | 10/14/1992SE |
| K892656 | Dri-Dye Check Strips (TM)-405JJX · Traditional | 05/22/1989SE |
| K882938 | Stat Fax(Tm)JJQ · Traditional | 09/09/1988SE |
| K873451 | Project 300 Microassay BP-12, Eia MinilabJJQ · Traditional | 11/04/1987SE |
Questions and answers
When was Stat FAX(TM)-2100 cleared by the FDA?
Stat FAX(TM)-2100 (K900224) received a 510(k) decision of Substantially Equivalent on March 1, 1990, 43 days after the submission was received.
What is the product code of K900224?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.