Labotech Automated Microtiter Analyzer
FDA 510(k) K922081 · Innovative Medical Systems, Inc.
510(k) numberK922081
Submission
- Device name
- Labotech Automated Microtiter Analyzer
- Applicant
- Innovative Medical Systems, Inc.
Warren, NJ, US - Received
- May 5, 1992
- Decision date
- September 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K973035 | Viola II Dental Camera SystemEIA · Traditional | 09/24/1997SE |
| K951469 | Bazooka SystemFNM · Traditional | 06/28/1995SE |
| K933184 | Positive Airway Pressure SystemBZD · Traditional | 11/28/1994SE |
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | 12/29/1992SE |
| K921005 | AutoloaderJQW · Traditional | 04/29/1992SE |
| K915457 | Phaco 20/20 System IHQC · Traditional | 02/24/1992SE |
| K915456 | Phaco 3000 LinearHQC · Traditional | 02/12/1992SE |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | 09/02/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | 04/27/1988SE |
| K853938 | LX 300 Tissue ProcessorIEO · Traditional | 10/10/1985SE |
Questions and answers
When was Labotech Automated Microtiter Analyzer cleared by the FDA?
Labotech Automated Microtiter Analyzer (K922081) received a 510(k) decision of Substantially Equivalent on September 2, 1992, 120 days after the submission was received.
What is the product code of K922081?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.