Dbest HCG 2 Iu/Ml Test Kit
FDA 510(k) K001215 · Ameritek, Inc.
510(k) numberK001215
Submission
- Device name
- Dbest HCG 2 Iu/Ml Test Kit
- Applicant
- Ameritek, Inc.
Seattle, WA, US - Received
- April 14, 2000
- Decision date
- June 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHI – Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional | Innovita (Tangshan) Biological Technology Co.… | 08/02/2024SE |
| K203272 | Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 01/31/2022SE |
| K172322 | Atellica IM Total hCG (ThCG)JHI · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/29/2018SE |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional | True Diagnostics, Inc. | 12/22/2017SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | Assure Tech. Co., Ltd. | 02/24/2016SE |
| K130456 | Wunder Pregnancy TestJHI · Traditional | James Nguyen | 04/08/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | Polymed Therapeutics, Inc. | 01/09/2014SE |
| K131166 | Sofia(R) HCG FiaJHI · Traditional | Quidel Corp. | 08/02/2013SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | Chemtron Biotech, Inc. | 05/30/2013SE |
| K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional | Polymed Therapeutics, Inc. | 07/17/2012SE |
More from Polymed Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 Dbest HCG 2 Iu/Ml Test Kit cleared by the FDA?
Dbest HCG 2 Iu/Ml Test Kit (K001215) received a 510(k) decision of Substantially Equivalent on June 22, 2000, 69 days after the submission was received.
What is the product code of K001215?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.