Dbset Multidrug Screen Test Kit
FDA 510(k) K990681 · Ameritek, Inc.
510(k) numberK990681
Submission
- Device name
- Dbset Multidrug Screen Test Kit
- Applicant
- Ameritek, Inc.
Seattle, WA, US - Received
- March 2, 1999
- Decision date
- July 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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|---|---|---|
| K001215 | Dbest HCG 2 Iu/Ml Test KitJHI · Abbreviated | 06/22/2000SE |
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| K983191 | Dbest Cocaine Test KitDIO · Traditional | 11/18/1998SE |
| K983190 | Dbest Opiates Test KitDJG · 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 Dbset Multidrug Screen Test Kit cleared by the FDA?
Dbset Multidrug Screen Test Kit (K990681) received a 510(k) decision of Substantially Equivalent on July 15, 1999, 135 days after the submission was received.
What is the product code of K990681?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.