510(k) K231007

Device: CEDIA Heroin Metabolite (6-AM) Assay
Applicant: Microgenics Corporation
510(k) number: K231007
Product code: DJG
Decision: Substantially Equivalent (SESE)
Decision date: 2023-09-27
Date received: 2023-04-07
Regulation: 862.3650
Classification name: Enzyme Immunoassay, Opiates
Medical specialty: Clinical Toxicology
Review panel: Clinical Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Amrit Takhar
Address: 46500 Kato Rd. Fremont CA US 94538 94538

FDA Registration Numbers

1063851
3003795116
3036649420
3043127647
3005641941
3004987297
3009585529
3023296261
1050155
2090110
2432235
9610529
3030413233
1832216
3009473156
3010220539
3008852306
3010852191
3030648160
3008416529
3008517993
3012073813
3005984081
3007838093
2029372
2027969
2000007960
1319681
3000308930
3023322455
2020952
3006048451
8043323
2087033
3009414546
3007606081
3005333358
2060833
3005345870
3010939897
3025041446
3004493545
3011559327
3024753119
3044466317
3010825766
3003917514
2031229
3016610313
2030633
3009212837
3010800486
3012725363
3013982035
3013684380
3011522054
2050012
2032364
3007126977
3010934853
3017904598
2250051
1649661
3032147516
2517506
3043196750
3008054239
3002642396
3008987086
3004175381
3009238284
2050010
3031697086
3003610499
3027519599
1910144
3006198300
2246703
3005360469
2030861

Source Documents

510(k) summary PDF

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K232597	LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)	Hangzhou Laihe Biotech Co., Ltd.	2024-01-09
K232736	Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test	Chemtron Biotech, Inc.	2023-12-20
K232659	Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup	Guangzhou Decheng Biotechnology Co., Ltd.	2023-12-13
K231752	ARK Hydrocodone Assay	Ark Diagnostics, Inc.	2023-11-09
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