Now Pregnancy Test Kit
FDA 510(k) K921211 · Bio Clinic Co.
510(k) numberK921211
Submission
- Device name
- Now Pregnancy Test Kit
- Applicant
- Bio Clinic Co.
St. Louis, MI, US - Received
- March 12, 1992
- Decision date
- May 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K930791 | American Power Conversions, Back-Ups 600FMF · Traditional | 08/06/1993SE |
| K932480 | PrismIOQ · Traditional | 07/21/1993SE |
| K926189 | Orthoderm Consummate Air Therapy Bed W/ScaleIOQ · Traditional | 06/24/1993SE |
| K921958 | Elisa Tube TSH TestJLW · Traditional | 07/02/1992SE |
| K922140 | Orthoderm Convertible IIIOQ · Traditional | 05/27/1992SE |
| K921212 | Mirco Elisa HPL Test KitJHI · Traditional | 05/07/1992SE |
| K920921 | Elisa Tube Prolactin Test KitCFT · Traditional | 04/08/1992SE |
| K920920 | Elisa Tube LH Test KitCEP · Traditional | 04/08/1992SE |
| K920918 | TMB Chromogen/Substrate Reagent SetJHI · Traditional | 04/07/1992SE |
| K920917 | Elisa Tube FSH Test Kit Enzyme Linked Immun. AssayCGJ · Traditional | 03/26/1992SE |
Questions and answers
When was Now Pregnancy Test Kit cleared by the FDA?
Now Pregnancy Test Kit (K921211) received a 510(k) decision of Substantially Equivalent on May 7, 1992, 56 days after the submission was received.
What is the product code of K921211?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.