Affinity (TM) HCG Immunit (TM)
FDA 510(k) K870627 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK870627
Submission
- Device name
- Affinity (TM) HCG Immunit (TM)
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- February 13, 1987
- Decision date
- May 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Affinity (TM) HCG Immunit (TM) cleared by the FDA?
Affinity (TM) HCG Immunit (TM) (K870627) received a 510(k) decision of Substantially Equivalent on May 28, 1987, 104 days after the submission was received.
What is the product code of K870627?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.