Pregnancy Beta-Hcg Card & Liquid Test
FDA 510(k) K880478 · Ampcor, Inc.
510(k) numberK880478
Submission
- Device name
- Pregnancy Beta-Hcg Card & Liquid Test
- Applicant
- Ampcor, Inc.
Bridgeport, NJ, US - Received
- February 4, 1988
- Decision date
- April 28, 1988
- 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 |
| K880328 | Hcg-NostickJHJ · Traditional | Organon Teknika Corp. | 03/15/1988SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K922297 | Infectious Mononucleosis Qik-Dot Im Dry Card TestKTN · Traditional | 07/14/1992SE |
| K922296 | Imfectious Mononucleosis Im Liquid Card TestKTN · Traditional | 07/14/1992SE |
| K910438 | Dipstick SalmonellaGRM · Traditional | 09/13/1991SE |
| K893873 | Single and Dual Band Dipstick HCG TestDHA · Traditional | 08/21/1989SE |
| K890048 | Quik-Dot ToxoplasmosisLLA · Traditional | 06/09/1989SE |
| K892146 | C Reactive Protein LiquidDCK · Traditional | 04/14/1989SE |
| K892119 | Quik-Dot C Reactive ProteinDCK · Traditional | 04/14/1989SE |
| K890025 | Quik-Dot Antistreptolysin-OGTQ · Traditional | 01/31/1989SE |
| K884750 | Group a Strep, Beta-StrepGTZ · Traditional | 12/22/1988SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | 05/17/1988SE |
Questions and answers
When was Pregnancy Beta-Hcg Card & Liquid Test cleared by the FDA?
Pregnancy Beta-Hcg Card & Liquid Test (K880478) received a 510(k) decision of Substantially Equivalent on April 28, 1988, 84 days after the submission was received.
What is the product code of K880478?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.