N-Acetylprocainamide Calibrator
FDA 510(k) K833385 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK833385
Submission
- Device name
- N-Acetylprocainamide Calibrator
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Mchenry, IL, US - Received
- September 29, 1983
- Decision date
- December 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLG – Coating, Liquid, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
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| K920419 | Il Test Dat Cal/Control Set D/EDLG · Traditional | Instrumentation Laboratory CO | 03/11/1992SE |
| K894524 | FPR Gentamicin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K894518 | FPR Amikacin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K894528 | FPR Phenytoin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/25/1989SE |
| K882766 | Emds Acetaminophen Calibrator No. 67636/95DLG · Traditional | Em Diagnostic Systems, Inc. | 08/23/1988SE |
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Questions and answers
When was N-Acetylprocainamide Calibrator cleared by the FDA?
N-Acetylprocainamide Calibrator (K833385) received a 510(k) decision of Substantially Equivalent on December 16, 1983, 78 days after the submission was received.
What is the product code of K833385?
The FDA product code is DLG – Coating, Liquid, Glc, a Class I (low risk) device regulated under 21 CFR 862.2250.