Iso-Data Immunoassay Network System
FDA 510(k) K843365 · Iso-Data, Inc.
510(k) numberK843365
Submission
- Device name
- Iso-Data Immunoassay Network System
- Applicant
- Iso-Data, Inc.
Mchenry, IL, US - Received
- August 28, 1984
- Decision date
- September 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2100
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113007 | Bionime Diabetes Management System VI.0JQP · Traditional | Bionime Corporation | 02/27/2012SE |
| K983468 | Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional | Selfcare, Inc. | 12/17/1998SE |
| K964460 | The RoboliteJQP · Traditional | Shai Syg Motion and Innovations, Ltd. | 01/24/1997SE |
| K953652 | Prenval IJQP · Traditional | Base Ten Systems, Inc. | 09/15/1995SE |
| K934111 | MR7000 with Time Manager Software (TMS)JQP · Traditional | Dynatech Laboratories, Inc. | 11/02/1994SE |
| K923316 | Expresso CartridgeJQP · Traditional | Bio-Rad Laboratories, Inc. | 02/23/1993SE |
| K893838 | Modified Model 570 Clinical Chemistry AnalyzerJQP · Traditional | Ciba Corning Diagnostics Corp. | 08/31/1989SE |
| K892060 | Cyberlab High Volume Drug Testing SystemJQP · Traditional | Syva Co. | 08/10/1989SE |
| K885292 | Cobas MFCJQP · Traditional | Roche Diagnostic Systems, Inc. | 03/22/1989SE |
| K881194 | Ria-QuickJQP · Traditional | Quantitative Technologies, Inc. | 06/01/1988SE |
More from Quantitative Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872430 | Iso-Data 500 Series Gamma CounterJJJ · Traditional | 08/21/1987SE |
| K872429 | Iso-Data 100 Series Gamma CounterJJJ · Traditional | 08/21/1987SE |
| K843434 | Iso-Data Centrifuges 1-A, 101, 2D, Etc.JQC · Traditional | 10/05/1984SE |
| K810631 | DPM CalculatorJQP · Traditional | 03/27/1981SE |
| K780813 | Idi GDR Data Reduction System · Traditional | 06/28/1978SE |
| K780790 | Idi 200 Gamma CounterJJJ · Traditional | 06/22/1978SE |
Questions and answers
When was Iso-Data Immunoassay Network System cleared by the FDA?
Iso-Data Immunoassay Network System (K843365) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 30 days after the submission was received.
What is the product code of K843365?
The FDA product code is JQP – Calculator/Data Processing Module, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2100.