B Hcg-Check
FDA 510(k) K831468 · Diagnostic Technology, Inc.
510(k) numberK831468
Submission
- Device name
- B Hcg-Check
- Applicant
- Diagnostic Technology, Inc.
Mchenry, IL, US - Received
- May 6, 1983
- Decision date
- June 22, 1983
- 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 |
|---|---|---|
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | 11/05/1991SE |
| K903612 | Ebv/Ea-Check TM Test KitLSE · Traditional | 10/16/1990SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | 06/20/1989SE |
| K890819 | Hsv-Check(Tm) Test KitHIS · Traditional | 06/20/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | 06/20/1989SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | 06/25/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | 04/29/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | 11/28/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | 04/04/1986SE |
Questions and answers
When was B Hcg-Check cleared by the FDA?
B Hcg-Check (K831468) received a 510(k) decision of Substantially Equivalent on June 22, 1983, 47 days after the submission was received.
What is the product code of K831468?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.