Cholinesterase (PTC) Reagent
FDA 510(k) K863202 · Sigma Diagnostics, Inc.
510(k) numberK863202
Submission
- Device name
- Cholinesterase (PTC) Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- August 19, 1986
- Decision date
- September 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIH – Colorimetry, Cholinesterase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3240
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103373 | Synchron Systems Cholinesterase (Chex) Model A53722DIH · Traditional | Beckman Coulter, Inc. | 02/07/2011SE |
| K061093 | Cholinesterase GEN.2 Test SystemDIH · Traditional | Roche Diagnostics Corp. | 07/03/2006SE |
| K051444 | Sentinel Cholinesterase LiquidDIH · Special | Sentinel Ch. Srl | 06/20/2005SE |
| K030045 | Olympus Cholinesterase Reagent (Catalog Number OSR6114)DIH · Traditional | Olympus America, Inc. | 02/21/2003SE |
| K023992 | Wiener Lab Colinesterasa AaDIH · Traditional | Wiener Laboratories Saic | 02/12/2003SE |
| K013750 | Advia 1650 Cholinesterase AssayDIH · Traditional | Bayer Diagnostics Corp. | 01/18/2002SE |
| K002792 | Careside CholinesteraseDIH · Traditional | Careside, Inc. | 11/08/2000SE |
| K001344 | Advia ImsDIH · Traditional | Bayer Corp. | 06/26/2000SE |
| K961656 | Test-Mate Che Cholinesterase Test SystemDIH · Traditional | Eqm Research, Inc. | 11/26/1996SE |
| K943367 | Il Test CholinesteraseDIH · Traditional | Instrumentation Laboratory CO | 02/05/1996SE |
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Questions and answers
When was Cholinesterase (PTC) Reagent cleared by the FDA?
Cholinesterase (PTC) Reagent (K863202) received a 510(k) decision of Substantially Equivalent on September 16, 1986, 28 days after the submission was received.
What is the product code of K863202?
The FDA product code is DIH – Colorimetry, Cholinesterase, a Class I (low risk) device regulated under 21 CFR 862.3240.