510(k) K210327
- Device
- First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
- Applicant
- W.H.P.M., Inc.
- 510(k) number
- K210327
- Product code
- QBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-12
- Date received
- 2021-02-04
- Regulation
- 862.3700
- Classification name
- Test, Propoxyphene, Over The Counter
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John Wan
- Address
- 5358 Irwindale Ave. Irwindale CA US 91706 91706
FDA Registration Numbers#
- 3043127647
- 3015821396
- 3010934853
- 3014223276
- 3007606081
- 3008741972
- 3009238284
- 3031697086
- 3008054239
- 3027519599
- 3012725363
- 3016447251
- 3030413233
- 1649661
- 3013223546
- 3030648160
- 3023322455
- 3010852191
- 3005345870
- 3031823359
- 3009585529
- 3032147516
- 3036649420
- 3013077867
- 3021186226
- 3008517993
- 3012073813
- 3005360469
- 2087033
- 3010220539
- 3009414546
- 3024463179
- 3004635103
- 3005984081
- 3024753119
- 3038614708
- 1910144
- 3006048451
- 3025041446
- 3003917514
- 3009212837
- 3017904598
- 2030633
- 3011522054
- 3014301129
Source Documents#
Legacy Summary#
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FDA Review#
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