Early Pregnancy Detection
FDA 510(k) K811398 · Immuchem Corp.
510(k) numberK811398
Submission
- Device name
- Early Pregnancy Detection
- Applicant
- Immuchem Corp.
Mchenry, IL, US - Received
- May 18, 1981
- Decision date
- May 29, 1981
- 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 |
|---|---|---|
| K883726 | Thyroid Stimulating Hormone (HTSH) Irma NeonatalJLW · Traditional | 12/15/1988SE |
| K871317 | Follicle Stimulating Hormone (HFSH)CGJ · Traditional | 05/20/1987SE |
| K871542 | Hprolactin KitCFT · Traditional | 05/14/1987SE |
| K865071 | Thyroid Stimulating Hormone (TSH Irma) Ria KitJLW · Traditional | 03/13/1987SE |
| K864144 | Luteinizing Hormone (Lh-Irma) Ria KitCEP · Traditional | 11/24/1986SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | 03/14/1986SE |
| K854094 | Immuchem Covalent Coat a Solid Phase RadioimmunoasJLS · Traditional | 02/28/1986SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | 05/04/1983SE |
| K822509 | Covalent Coat Ria KitCFP · Traditional | 09/28/1982SE |
| K822140 | Immuchem Covalent-CoatJKC · Traditional | 08/05/1982SE |
Questions and answers
When was Early Pregnancy Detection cleared by the FDA?
Early Pregnancy Detection (K811398) received a 510(k) decision of Substantially Equivalent on May 29, 1981, 11 days after the submission was received.
What is the product code of K811398?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.