510(k) K212221
- Device
- Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
- Applicant
- Diazyme Laboratories, Inc.
- 510(k) number
- K212221
- Product code
- DHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-13
- Date received
- 2021-07-16
- Regulation
- 862.1155
- Classification name
- System, Test, Human Chorionic Gonadotropin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chao Dou
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers
- 9610126
- 3004434309
- 1219913
- 3002809144
- 3042471840
- 2020726
- 2122870
- 3023268435
- 1649661
- 1415939
- 2250051
- 2432235
- 2032682
- 2517506
- 9680746
- 3017125176
- 1036362
- 9610240
- 2246703
- 3000308930
- 3023322455
- 2032839
- 3005094123
- 3016244760
- 3002806944
- 3006479639
- 3002642396
- 3004635103
- 3005333358
- 3007111389
- 3011522054
- 3012963943
- 3007606081
- 1319681
- 3008344661
- 3006198300
- 3004192065
- 3002637618
- 3017019647
- 3016438761
- 3005643513
- 3010825766
Source Documents
510(k) summary PDF not indicated by FDA
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| K130020 | ACCESS TOTAL BHCG (5TH IS) | Beckman Coulter, Inc. | 2013-10-01 |
| K131037 | LIAISON XL HCG | DiaSorin, Inc. | 2013-09-06 |
| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 |