Answer Quick and Simple At-Home Pregnancy Test
FDA 510(k) K904782 · Carter Products
510(k) numberK904782
Submission
- Device name
- Answer Quick and Simple At-Home Pregnancy Test
- Applicant
- Carter Products
Cranbury, NJ, US - Received
- October 22, 1990
- Decision date
- December 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K955672 | Trojan Polyurethane Condom (Modification)MOL · Traditional | 08/29/1996SE |
| K942697 | Trojan Polyurethane CondomMOL · Traditional | 06/22/1995SE |
| K912901 | Trojan (Tm-Tbd) CondomHIS · Traditional | 02/03/1992SE |
| K904273 | Magnum Plus Latex Condoms with Spermicidal Lub.LTZ · Traditional | 10/31/1990SE |
| K901202 | Trojan Naturalamb Lubricated Natural ModifiedHIS · Traditional | 06/19/1990SE |
| K901201 | Trojan Ribbed Latex Condoms W/Sperm. ModifiedHIS · Traditional | 04/16/1990SE |
| K901200 | Trojan for Women Latex Condoms W/Spermi. ModifiedHIS · Traditional | 04/16/1990SE |
| K901199 | Trojan-Enz Latex Condoms W/Spermicidal ModifiedHIS · Traditional | 04/16/1990SE |
| K901198 | Trojan Plus 2 Latex Condoms W/Spermicidal ModifiedHIS · Traditional | 04/16/1990SE |
| K901197 | Trojan Extra Strength Lubri. Condoms Modi. LabelHIS · Traditional | 04/16/1990SE |
Questions and answers
When was Answer Quick and Simple At-Home Pregnancy Test cleared by the FDA?
Answer Quick and Simple At-Home Pregnancy Test (K904782) received a 510(k) decision of Substantially Equivalent on December 6, 1990, 45 days after the submission was received.
What is the product code of K904782?
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.