Anticonvulsants III Calibrator Kit
FDA 510(k) K780733 · Vitek Systems, Inc.
510(k) numberK780733
Submission
- Device name
- Anticonvulsants III Calibrator Kit
- Applicant
- Vitek Systems, Inc.
Mchenry, IL, US - Received
- May 2, 1978
- Decision date
- June 22, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKH – Gas Chromatography, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K801276 | Dupont Prep Appli. for Phenobarbital,DKH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/20/1980SE |
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| 510(k) | Device | Decision |
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| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
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| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
Questions and answers
When was Anticonvulsants III Calibrator Kit cleared by the FDA?
Anticonvulsants III Calibrator Kit (K780733) received a 510(k) decision of Substantially Equivalent on June 22, 1978, 51 days after the submission was received.
What is the product code of K780733?
The FDA product code is DKH – Gas Chromatography, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.