Chem-Stat Analyzer
FDA 510(k) K840340 · Ocean Scientific, Inc.
510(k) numberK840340
Submission
- Device name
- Chem-Stat Analyzer
- Applicant
- Ocean Scientific, Inc.
Walker, MI, US - Received
- January 25, 1984
- Decision date
- March 23, 1984
- 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 |
|---|---|---|
| K893810 | Immuno-Wash Automated Tube WasherJQW · Traditional | 08/03/1989SE |
| K873638 | Micro-Chem AnalyzerJJQ · Traditional | 09/29/1987SE |
| K864731 | Ocean Scientific VDRL TestGMQ · Traditional | 03/10/1987SE |
| K863976 | Ocean Scientific VacutestJKA · Traditional | 10/24/1986SE |
| K860987 | Mini-Chem AnalyzerJJQ · Traditional | 05/05/1986SE |
Questions and answers
When was Chem-Stat Analyzer cleared by the FDA?
Chem-Stat Analyzer (K840340) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 58 days after the submission was received.
What is the product code of K840340?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.