510(k) K962888
- Device
- AFFIRM ONE-STEP HOME PREGNANCY TEST
- Applicant
- ATHENA MEDICAL CORP.
- 510(k) number
- K962888
- Product code
- LCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-23
- Date received
- 1996-07-24
- Regulation
- 862.1155
- Classification name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BUCK
- Address
- 10180 SW Nimbus Ave. Suite J-5 Portland OR US 97223 97223
FDA Registration Numbers#
- 3014301129
- 1423537
- 3010864358
- 1645225
- 9710094
- 3043127647
- 3009585529
- 3021448148
- 3005128563
- 3030413233
- 1832216
- 3033530347
- 3010220539
- 3006479639
- 3010822231
- 3030726486
- 3008852306
- 2250030
- 3006191977
- 3010852191
- 3030648160
- 9615507
- 3008517993
- 3012073813
- 3005984081
- 3007838093
- 2029372
- 3007583565
- 3017887566
- 3003741676
- 3023322455
- 3013735968
- 3006048451
- 8043323
- 2087033
- 3009414546
- 3007606081
- 3002792284
- 3008573045
- 2060833
- 3013077867
- 3005345870
- 3016447251
- 3005951403
- 3030230672
- 3014848805
- 3006635320
- 3024753119
- 3018126397
- 3012312061
- 1313700
- 3003917514
- 3013160357
- 2031229
- 3033507883
- 2030633
- 1720839
- 3025349997
- 3015729142
- 3012725363
- 3014171027
- 3005630901
- 3011522054
- 3014015501
- 2032364
- 3005395953
- 3007126977
- 3017904598
- 1649661
- 3005216656
- 3006621318
- 3043196750
- 3013501873
- 3008808560
- 3008054239
- 3016733849
- 3003791481
- 3009238284
- 2025760
- 3005569927
Source Documents#
Other 510(k) Records For Product Code LCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | 2025-02-13 |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC | 2025-01-15 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | 2024-12-20 |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. | 2024-05-31 |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | 2024-04-05 |
| K233174 | FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 |
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co., Ltd. | 2024-01-26 |
Legacy Summary#
summary
FDA Review#
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