Modified Model 570 Clinical Chemistry Analyzer
FDA 510(k) K893838 · Ciba Corning Diagnostics Corp.
510(k) numberK893838
Submission
- Device name
- Modified Model 570 Clinical Chemistry Analyzer
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- May 24, 1989
- Decision date
- August 31, 1989
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K871853 | V-Marc 88A ComputerJQP · Traditional | V.Marc, A Div. of Pictorial, Inc. | 07/16/1987SE |
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|---|---|---|
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| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Modified Model 570 Clinical Chemistry Analyzer cleared by the FDA?
Modified Model 570 Clinical Chemistry Analyzer (K893838) received a 510(k) decision of Substantially Equivalent on August 31, 1989, 99 days after the submission was received.
What is the product code of K893838?
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.