Ucg-Lyphotest
FDA 510(k) K791309 · Wampole Laboratories
510(k) numberK791309
Submission
- Device name
- Ucg-Lyphotest
- Applicant
- Wampole Laboratories
Mchenry, IL, US - Received
- July 16, 1979
- Decision date
- July 30, 1979
- 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 |
|---|---|---|
| K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K965129 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K911444 | Rubella Virus Immunological Test SystemLFX · Traditional | 08/30/1991SE |
| K882896 | One-Step HCGDHA · Traditional | 10/31/1988SE |
| K883004 | Mono-Plus(Tm)KTN · Traditional | 08/04/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | 03/01/1988SE |
| K875161 | Mat (TM) Microalbumin TestDCF · Traditional | 02/17/1988SE |
| K790986 | RF ControlsDMR · Traditional | 06/28/1979SE |
| K781794 | Beta-TecJHI · Traditional | 12/29/1978SE |
| K760336 | Biocept-GJHI · Traditional | 11/12/1976SE |
Questions and answers
When was Ucg-Lyphotest cleared by the FDA?
Ucg-Lyphotest (K791309) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 14 days after the submission was received.
What is the product code of K791309?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.