Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit No
FDA 510(k) K854059 · Bioclinical Systems, Inc.
510(k) numberK854059
Submission
- Device name
- Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit No
- Applicant
- Bioclinical Systems, Inc.
St.Louis, MO, US - Received
- October 3, 1985
- Decision date
- January 13, 1986
- 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 |
|---|---|---|
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | 06/30/1995SE |
| K945911 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsJTZ · Traditional | 04/04/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | 02/03/1994SE |
| K873086 | Round 1JXA · Traditional | 08/24/1987SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | 04/21/1986SE |
| K860333 | Micro-Elisa HLH Test Kit MonoclonalCEP · Traditional | 04/21/1986SE |
| K855227 | Micro-Eia Theophylline Test Kit MonoclonalKLS · Traditional | 04/11/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | 01/07/1986SE |
| K850257 | BCS Glucose Colorimetric TestCGA · Traditional | 03/05/1985SE |
Questions and answers
When was Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit No cleared by the FDA?
Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit No (K854059) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 102 days after the submission was received.
What is the product code of K854059?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.