Pregna B-Anti Human Chorionic Gonadotro
FDA 510(k) K802343 · Intl. Diagnostic, Inc.
510(k) numberK802343
Submission
- Device name
- Pregna B-Anti Human Chorionic Gonadotro
- Applicant
- Intl. Diagnostic, Inc.
Mchenry, IL, US - Received
- September 26, 1980
- Decision date
- October 10, 1980
- 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 |
|---|---|---|
| K841853 | Preg-Beta One Hour Tube TestJHJ · Traditional | 06/22/1984SE |
| K840833 | Preg Beta Blus SlideJHJ · Traditional | 05/30/1984SE |
| K834584 | Nabi Crp-Q.S. TestDCN · Traditional | 02/27/1984SE |
| K840005 | Nabi Rf-Q.S. TestDHR · Traditional | 02/13/1984SE |
| K780321 | Pregnancy Test Kit, Over-The-CounterLCX · Traditional | 04/04/1978SE |
Questions and answers
When was Pregna B-Anti Human Chorionic Gonadotro cleared by the FDA?
Pregna B-Anti Human Chorionic Gonadotro (K802343) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 14 days after the submission was received.
What is the product code of K802343?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.