Fact* Home Pregnancy Test
FDA 510(k) K810581 · Ortho Pharmaceutical Corp.
510(k) numberK810581
Submission
- Device name
- Fact* Home Pregnancy Test
- Applicant
- Ortho Pharmaceutical Corp.
Mchenry, IL, US - Received
- March 3, 1981
- Decision date
- March 17, 1981
- 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 |
|---|---|---|
| K955648 | K-Y Personal LubricantHIS · Traditional | 06/21/1996SE |
| K934516 | Advance Pregnancy Test ModificationLCX · Traditional | 02/24/1994SE |
| K914990 | Advance(R) Pregnancy TestLCX · Traditional | 12/23/1991SE |
| K893488 | Pulsatile Pump for Gonadorelin AcetateFRN · Traditional | 10/31/1989SE |
| K881151 | MicroscrapeLXK · Traditional | 04/06/1988SE |
| K800754 | Nickerson's Med. Selective Culture MediuJSJ · Traditional | 04/29/1980SE |
| K792634 | Conceptrol/Thin ProphylacticsHIS · Traditional | 01/16/1980SE |
| K790087 | Lubricant, Otrho PersonalKMJ · Traditional | 02/01/1979SE |
Questions and answers
When was Fact* Home Pregnancy Test cleared by the FDA?
Fact* Home Pregnancy Test (K810581) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 14 days after the submission was received.
What is the product code of K810581?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.