510(k) K242135

Device: Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
Applicant: Nanjing Synthgene Medical Technology Co., Ltd.
510(k) number: K242135
Product code: LCX
Decision: Substantially Equivalent (SESE)
Decision date: 2025-01-31
Date received: 2024-07-22
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: N

Related Records

Applicant Contact

Contact: Alvin Qian
Address: Bldg. B6-2, # 9, Weidi Rd., Xianlin University Town Xianlin Subdistrict, Qixia District Nanjing CN 210000 210000

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

510(k) summary PDF

Other 510(k) Records For Product Code LCX

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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
K230741	Macro & Micro-Test HCG Pregnancy Test Midstream	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	2023-10-13