Plus Urine HCG Assay
FDA 510(k) K840738 · Monoclonal Antibodies, Inc.
510(k) numberK840738
Submission
- Device name
- Plus Urine HCG Assay
- Applicant
- Monoclonal Antibodies, Inc.
Walker, MI, US - Received
- February 21, 1984
- Decision date
- April 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHJ – Agglutination Method, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972606 | Pregnacol Pregnancy TestJHJ · Traditional | Immunostics Inc., | 08/29/1997SE |
| K921968 | In Vitro Diagnostic Reagent Set, Indir. Preg. TestJHJ · Traditional | Tech-Co, Inc. | 06/28/1996SE |
| K935863 | Sas(Tm) Direct Monoclonal HCGJHJ · Traditional | Sa Scientific, Inc. | 02/24/1994SE |
| K926112 | Accutex Beta-Hcg TestJHJ · Traditional | J.S. Medical Assoc. | 07/28/1993SE |
| K930609 | Sas(Tm) Monoclonal Hcg-SlideJHJ · Traditional | Sa Scientific, Inc. | 03/29/1993SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | Tech-Co, Inc. | 03/24/1992SE |
| K910946 | Clearview HCGJHJ · Traditional | Unipath , Ltd. | 04/01/1991SE |
| K881435 | Pregnospia IIJHJ · Traditional | Organon Teknika Corp. | 05/27/1988SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | Ampcor, Inc. | 05/17/1988SE |
| K880478 | Pregnancy Beta-Hcg Card & Liquid TestJHJ · Traditional | Ampcor, Inc. | 04/28/1988SE |
More from Ampcor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874863 | Ramp Herpes Simplex Virus (HSV) (CCT)GQN · Traditional | 02/16/1988SE |
| K871726 | Ovuquick Self-Test (Ovuquick; Ramp LH Assay)CEP · Traditional | 07/27/1987SE |
| K863744 | HCG Control KitJJX · Traditional | 11/05/1986SE |
| K860924 | Ramp Progesturine PDG ASSAY--48 Test KitJLS · Traditional | 07/02/1986SE |
| K854611 | Ramp Urine HCG AssayJHI · Traditional | 12/30/1985SE |
| K850730 | Model Serum HCG AssayJHI · Traditional | 04/02/1985SE |
| K850480 | Ovu Stick Self-Test -ModificationCEP · Traditional | 03/05/1985SE |
| K843284 | Ovustick Self-TestCEP · Traditional | 12/11/1984SE |
| K840412 | Ovu Stick Urine HLH KitCEP · Traditional | 04/13/1984SE |
| K833504 | Pregnastick Urine HCG KitJHJ · Traditional | 01/09/1984SE |
Questions and answers
When was Plus Urine HCG Assay cleared by the FDA?
Plus Urine HCG Assay (K840738) received a 510(k) decision of Substantially Equivalent on April 19, 1984, 58 days after the submission was received.
What is the product code of K840738?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.