Immulite (TM) Automated Immunoassay Analyzer
FDA 510(k) K905215 · Cirrus Diagnostics, Inc.
510(k) numberK905215
Submission
- Device name
- Immulite (TM) Automated Immunoassay Analyzer
- Applicant
- Cirrus Diagnostics, Inc.
Chester, NY, US - Received
- November 20, 1990
- Decision date
- January 11, 1991
- 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 |
|---|---|---|
| K921704 | Immulite(R) FSHCGJ · Traditional | 06/09/1992SE |
| K920411 | Immulite HLHCEP · Traditional | 03/11/1992SE |
| K914833 | Immulite DigoxinDPO · Traditional | 11/22/1991SE |
| K911796 | Immulite(Tm) HCGDHA · Traditional | 06/20/1991SE |
| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | 04/29/1991SE |
| K910261 | Immulite(Tm) Total T4KLI · Traditional | 04/16/1991SE |
| K905648 | CRP Lipid Reagent Test PackCHH · Traditional | 03/06/1991SE |
| K905214 | Immulite (TM) Total T3CDP · Traditional | 02/01/1991SE |
| K905769 | Immulite Hs-TshJLW · Traditional | 01/31/1991SE |
Questions and answers
When was Immulite (TM) Automated Immunoassay Analyzer cleared by the FDA?
Immulite (TM) Automated Immunoassay Analyzer (K905215) received a 510(k) decision of Substantially Equivalent on January 11, 1991, 52 days after the submission was received.
What is the product code of K905215?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.