Elisa Systme
FDA 510(k) K781269 · Gilford Instrument Laboratories, Inc.
510(k) numberK781269
Submission
- Device name
- Elisa Systme
- Applicant
- Gilford Instrument Laboratories, Inc.
Mchenry, IL, US - Received
- July 24, 1978
- Decision date
- December 4, 1978
- 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 |
|---|---|---|
| K823233 | Sba 300 Clinical Chemistry AnalyzerJJC · Traditional | 11/29/1982SE |
| K821583 | Ames/Gilford Optimate Clin. Chem & TherJJF · Traditional | 06/24/1982SE |
| K802609 | Chemistry Analyzer Impact 400JJE · Traditional | 11/26/1980SE |
| K801889 | Model 203S Clinical Chemistry AnalyzerJJE · Traditional | 09/26/1980SE |
| K800085 | System 203 Chemistry AnalyzerJJE · Traditional | 02/13/1980SE |
| K792361 | System 103 Chemistry AnalyzerJJE · Traditional | 12/27/1979SE |
| K792087 | Microflame PhotometerJJO · Traditional | 11/13/1979SE |
| K791968 | Eia (Elisa) ReaderJJQ · Traditional | 10/17/1979SE |
| K790073 | Analyzer, Impact 100JJI · Traditional | 02/22/1979SE |
| K790072 | Analyzer, Impact 200JJE · Traditional | 02/22/1979SE |
Questions and answers
When was Elisa Systme cleared by the FDA?
Elisa Systme (K781269) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 133 days after the submission was received.
What is the product code of K781269?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.