Accutex Beta-Hcg Test
FDA 510(k) K926112 · J.S. Medical Assoc.
510(k) numberK926112
Submission
- Device name
- Accutex Beta-Hcg Test
- Applicant
- J.S. Medical Assoc.
Natick, MA, US - Received
- December 3, 1992
- Decision date
- July 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K880328 | Hcg-NostickJHJ · Traditional | Organon Teknika Corp. | 03/15/1988SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K932752 | Visi-SpotJTO · Traditional | 11/05/1993SE |
| K932688 | Eye Spot Im TestKTN · Traditional | 09/08/1993SE |
| K932180 | Eye Spot CRP TestDCN · Traditional | 08/23/1993SE |
| K932551 | Accutex Im Latex TestKTN · Traditional | 08/09/1993SE |
| K924332 | Accutex CRP Latex TestDCK · Traditional | 12/07/1992SE |
| K924247 | Accutex Aso Latex TestGTQ · Traditional | 12/07/1992SE |
| K924036 | Accutex Rheumatiod Factor (RF) Latex TestDHR · Traditional | 12/01/1992SE |
| K924248 | Accutex Sle Latex TestLJM · Traditional | 11/02/1992SE |
| K924037 | Accutex Im RBC TestKTN · Traditional | 11/02/1992SE |
| K912717 | J&S Uibc ReagentsJMO · Traditional | 09/25/1991SE |
Questions and answers
When was Accutex Beta-Hcg Test cleared by the FDA?
Accutex Beta-Hcg Test (K926112) received a 510(k) decision of Substantially Equivalent on July 28, 1993, 237 days after the submission was received.
What is the product code of K926112?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.