Auto-Eia
FDA 510(k) K873583 · Labsystems, Inc.
510(k) numberK873583
Submission
- Device name
- Auto-Eia
- Applicant
- Labsystems, Inc.
Morton Grove, IL, US - Received
- September 3, 1987
- Decision date
- September 22, 1987
- 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 |
|---|---|---|
| K923365 | Tilt/Reduced Shear Semi-Recline Seating SystemITI · Traditional | 03/24/1993SE |
| K896474 | Resubmitted Fecatwin Sensitive - Feca-EiaKHE · Traditional | 01/25/1990SE |
| K890154 | Modified Labysystems' Toxoplasma Gondii Igg EiaLGD · Traditional | 02/07/1989SE |
| K890091 | Modified Labsystems' Rubella Igg Eia Test KitLFX · Traditional | 02/03/1989SE |
| K881243 | Rubella Igg - Eia Test Kit Number 61 07 201LFX · Traditional | 04/04/1988SE |
| K873780 | Modification Rubella Igm Eia Test KitLFX · Traditional | 10/15/1987SE |
| K872252 | Modified Toxoplasma Gondii Igg Eia Test KitLGD · Traditional | 07/01/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | 10/01/1986SE |
| K862431 | Rubella Igm Eia Test KitLFX · Traditional | 08/08/1986SE |
| K862216 | Toxoplasma Gondii Igg Eia Test Kit (Amendment)LGD · Traditional | 06/30/1986SE |
Questions and answers
When was Auto-Eia cleared by the FDA?
Auto-Eia (K873583) received a 510(k) decision of Substantially Equivalent on September 22, 1987, 19 days after the submission was received.
What is the product code of K873583?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.