Ace(Tm) Clin Chem Syst W/Opt Ion Select Electr(Ise)
FDA 510(k) K933862 · Schiapparelli Biosystems, Inc.
510(k) numberK933862
Submission
- Device name
- Ace(Tm) Clin Chem Syst W/Opt Ion Select Electr(Ise)
- Applicant
- Schiapparelli Biosystems, Inc.
Columbia, MD, US - Received
- August 9, 1993
- Decision date
- October 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
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| K991733 | Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional | 07/13/1999SE |
| K981377 | Ace T4 Reagent T4 CalibratorsKLI · Traditional | 06/10/1998SE |
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | 06/10/1998SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | 11/12/1997SE |
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | 11/12/1997SE |
| K973581 | Ace Valproic Acid Reagent, AED CalibratorsLEG · Traditional | 11/12/1997SE |
| K973536 | Ace Phenobarbital Reagent/Aed CalibratorsDLJ · Traditional | 11/06/1997SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | 11/04/1997SE |
| K973535 | Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional | 10/20/1997SE |
| K971526 | Ace Hdl-C ReagentLBS · Traditional | 05/21/1997SE |
Questions and answers
When was Ace(Tm) Clin Chem Syst W/Opt Ion Select Electr(Ise) cleared by the FDA?
Ace(Tm) Clin Chem Syst W/Opt Ion Select Electr(Ise) (K933862) received a 510(k) decision of Substantially Equivalent on October 12, 1993, 64 days after the submission was received.
What is the product code of K933862?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.