In Vitro Diagnostic Reagent Set, Indir. Preg. Test
FDA 510(k) K921968 · Tech-Co, Inc.
510(k) numberK921968
Submission
- Device name
- In Vitro Diagnostic Reagent Set, Indir. Preg. Test
- Applicant
- Tech-Co, Inc.
Placentia, CA, US - Received
- April 27, 1992
- Decision date
- June 28, 1996
- 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 |
| 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 |
| K880328 | Hcg-NostickJHJ · Traditional | Organon Teknika Corp. | 03/15/1988SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K923376 | Visual HCG Pregnancy TestJHI · Traditional | 10/01/1992SE |
| K920766 | T4 Eia Bead AssayCDX · Traditional | 04/17/1992SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | 03/24/1992SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | 07/10/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | 05/17/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | 10/13/1988SE |
| K883683 | HemoglobinGJZ · Traditional | 10/06/1988SE |
| K883386 | ChlorideCHJ · Traditional | 10/06/1988SE |
| K881173 | Aspartate Aminotransferase (Colorimetric Method)CIQ · Traditional | 06/07/1988SE |
| K881172 | Bilirubin (Direct)CIG · Traditional | 06/07/1988SE |
Questions and answers
When was In Vitro Diagnostic Reagent Set, Indir. Preg. Test cleared by the FDA?
In Vitro Diagnostic Reagent Set, Indir. Preg. Test (K921968) received a 510(k) decision of Substantially Equivalent on June 28, 1996, 1,523 days after the submission was received.
What is the product code of K921968?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.