Sba 300 Clinical Chemistry Analyzer
FDA 510(k) K823233 · Gilford Instrument Laboratories, Inc.
510(k) numberK823233
Submission
- Device name
- Sba 300 Clinical Chemistry Analyzer
- Applicant
- Gilford Instrument Laboratories, Inc.
Mchenry, IL, US - Received
- October 29, 1982
- Decision date
- November 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2150
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K945915 | Avl Omni AnalyzerJJC · Traditional | Avl Scientific Corp. | 04/05/1995SE |
| K945584 | Nova 16 AnalyzerJJC · Traditional | Nova Biomedical Corp. | 02/08/1995SE |
| K943376 | Opera SystemJJC · Traditional | Miles, Inc. | 09/14/1994SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | Technicon Instruments Corp. | 07/17/1990SE |
| K901141 | Paramax 520, Paramax 720 and Paramax 720ZXJJC · Traditional | Baxter Healthcare Corp | 04/09/1990SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | Alpkem Corp. | 02/17/1989SE |
| K881056 | Amresco Flow Pac Random Access Liquid #4901030JJC · Traditional | American Research Products Co. | 11/15/1988SE |
| K875105 | Technicon Smac 3 SystemJJC · Traditional | Technicon Instruments Corp. | 02/16/1988SE |
| K870998 | Technicon Ra-Xt(Tm) System ImmunoassaysJJC · Traditional | Technicon Instruments Corp. | 05/26/1987SE |
| K862561 | Technicon Ra-Xt System with AnalytesJJC · Traditional | Technicon Instruments Corp. | 10/20/1986SE |
More from Technicon Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K821583 | Ames/Gilford Optimate Clin. Chem & TherJJF · Traditional | 06/24/1982SE |
| K802609 | Chemistry Analyzer Impact 400JJE · Traditional | 11/26/1980SE |
| K801889 | Model 203S Clinical Chemistry AnalyzerJJE · Traditional | 09/26/1980SE |
| K800085 | System 203 Chemistry AnalyzerJJE · Traditional | 02/13/1980SE |
| K792361 | System 103 Chemistry AnalyzerJJE · Traditional | 12/27/1979SE |
| K792087 | Microflame PhotometerJJO · Traditional | 11/13/1979SE |
| K791968 | Eia (Elisa) ReaderJJQ · Traditional | 10/17/1979SE |
| K790073 | Analyzer, Impact 100JJI · Traditional | 02/22/1979SE |
| K790072 | Analyzer, Impact 200JJE · Traditional | 02/22/1979SE |
| K781269 | Elisa SystmeJJQ · Traditional | 12/04/1978SE |
Questions and answers
When was Sba 300 Clinical Chemistry Analyzer cleared by the FDA?
Sba 300 Clinical Chemistry Analyzer (K823233) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 31 days after the submission was received.
What is the product code of K823233?
The FDA product code is JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2150.