Pregna-Cert, Slide Pregnancy Test
FDA 510(k) K831180 · Diagnostic Specialties
510(k) numberK831180
Submission
- Device name
- Pregna-Cert, Slide Pregnancy Test
- Applicant
- Diagnostic Specialties
Mchenry, IL, US - Received
- April 11, 1983
- Decision date
- May 27, 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 |
|---|---|---|
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | 09/02/1997SE |
| K941001 | Enzip Immunoturbidmetric Fibrinogen Assay KitGIS · Traditional | 08/30/1994SE |
| K930823 | Protein-Bound Glucose Assayn KitLCP · Traditional | 08/19/1993SE |
| K922032 | Enzip Urinary Microalbumin TestJIR · Traditional | 07/30/1992SE |
| K823109 | Generic Pregnancy TestLCX · Traditional | 11/10/1982SE |
| K813608 | Potassium Reagent SetCEJ · Traditional | 01/22/1982SE |
| K813412 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 12/31/1981SE |
Questions and answers
When was Pregna-Cert, Slide Pregnancy Test cleared by the FDA?
Pregna-Cert, Slide Pregnancy Test (K831180) received a 510(k) decision of Substantially Equivalent on May 27, 1983, 46 days after the submission was received.
What is the product code of K831180?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.