Perfecta Pregnancy Test
FDA 510(k) K965184 · Wyntek Diagnostics, Inc.
510(k) numberK965184
Submission
- Device name
- Perfecta Pregnancy Test
- Applicant
- Wyntek Diagnostics, Inc.
San Diego, CA, US - Received
- December 24, 1996
- Decision date
- February 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 09/09/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | Assure Tech., LLC | 02/13/2025SE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional | Nanjing Synthgene Medical Technology Co., Ltd. | 01/31/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | Assure Tech., LLC | 01/15/2025SE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | Andon Health Co, Ltd. | 12/20/2024SE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 10/11/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 08/13/2024SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 06/21/2024SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 05/31/2024SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992658 | Osom Ultra Strep a Test, Model 147GTY · Traditional | 01/18/2000SE |
| K990578 | Osom Card II Hcg-Urine Test, Model 102JHI · Traditional | 03/09/1999SE |
| K990576 | Osom Card Pregnancy Test, Model 103LCX · Traditional | 03/09/1999SE |
| K974159 | Osom Hcg-Urine Test Model 101JHI · Traditional | 12/24/1997SE |
| K973879 | Osom Card Hcg-Urine TestJHI · Traditional | 11/04/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | 08/26/1997SE |
| K965227 | Osom Classic Hcg-Urine Test (115)JHI · Traditional | 02/04/1997SE |
| K961423 | Osom Strep a TestGTZ · Traditional | 10/11/1996SE |
| K955141 | Osom HCG Combo TestJJX · Traditional | 12/06/1995SE |
| K954178 | Osom Pregnancy TestLCX · Traditional | 10/23/1995SE |
Questions and answers
When was Perfecta Pregnancy Test cleared by the FDA?
Perfecta Pregnancy Test (K965184) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 42 days after the submission was received.
What is the product code of K965184?
The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.