Dbest Opiates Test Kit
FDA 510(k) K983190 · Ameritek, Inc.
510(k) numberK983190
Submission
- Device name
- Dbest Opiates Test Kit
- Applicant
- Ameritek, Inc.
Seattle, WA, US - Received
- September 11, 1998
- Decision date
- November 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K001215 | Dbest HCG 2 Iu/Ml Test KitJHI · Abbreviated | 06/22/2000SE |
| K990873 | Dbest Urinary Tract Infection Test Kit for Home-UseJMT · Traditional | 09/01/1999SE |
| K990681 | Dbset Multidrug Screen Test KitDKZ · Traditional | 07/15/1999SE |
| K984269 | Dbest Occult Blood Test KitKHE · Traditional | 05/11/1999SE |
| K983191 | Dbest Cocaine Test KitDIO · Traditional | 11/18/1998SE |
| K983189 | Dbest Methamphetamines Test KitLAF · Traditional | 11/18/1998SE |
| K983188 | Dbest Tetrahydrocannabinol Test KitLDJ · Traditional | 11/18/1998SE |
| K981504 | Dbest Amphetamines Test KitDKZ · Traditional | 08/06/1998SE |
| K974508 | Dbest One-Step Ovulation TestCEP · Traditional | 02/02/1998SE |
| K973957 | Dbest One-Step HCG Serum/Urine TestJHI · Traditional | 12/17/1997SE |
Questions and answers
When was Dbest Opiates Test Kit cleared by the FDA?
Dbest Opiates Test Kit (K983190) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 68 days after the submission was received.
What is the product code of K983190?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.