510(k) K964574
- Device
- AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
- Applicant
- ATHENA MEDICAL CORP.
- 510(k) number
- K964574
- Product code
- JHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-21
- Date received
- 1996-11-14
- Regulation
- 862.1155
- Classification name
- Visual, Pregnancy Hcg, Prescription Use
- 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
- PATRICIA FEETHAM
- Address
- 10180 SW Nimbus Ave. Suite J-5 Portland OR US 97223 97223
FDA Registration Numbers#
- 3010864358
- 1645225
- 9710094
- 3043127647
- 3003030793
- 3005641941
- 3009585529
- 2432235
- 3030413233
- 1832216
- 3030726486
- 9612316
- 2250030
- 3010852191
- 3030648160
- 1420054
- 3012073813
- 3005984081
- 3007838093
- 3033751096
- 8020888
- 3004569406
- 2029372
- 2027969
- 3017887566
- 3023322455
- 3013735968
- 9610633
- 8043323
- 2087033
- 3007606081
- 3002792284
- 3004043187
- 2060833
- 3005345870
- 3016447251
- 1222302
- 3014848805
- 2032087
- 1061932
- 3018126397
- 3012312061
- 1313700
- 3003917514
- 3013160357
- 2031229
- 2024674
- 3033507883
- 2030633
- 2435505
- 3017772438
- 3025349997
- 3015729142
- 3012725363
- 3005630901
- 3011522054
- 2050012
- 3014015501
- 2032364
- 3022178699
- 1649661
- 3005216656
- 3006621318
- 8031673
- 2032682
- 3013501873
- 3002637618
- 3003791481
- 2025760
- 3005569927
- 1219913
- 3005529799
- 3010131137
- 3012494290
- 3025672
- 3027519599
- 3006198300
- 2246703
- 3005360469
- 3021090658
Source Documents#
Other 510(k) Records For Product Code JHI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) | True Diagnostics, Inc. | 2017-12-22 |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | Assure Tech. Co., Ltd. | 2016-02-24 |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | 2014-04-08 |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | 2014-01-09 |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | 2013-08-02 |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | Chemtron Biotech, Inc. | 2013-05-30 |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. | 2012-07-17 |
| K112315 | HOME PREGNANCY TEST | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 |
| K102175 | RAPIDVUE HCG TEST | Quidel Corporation | 2010-08-25 |
| K072264 | FASTPACK HCG IMMUNOASSAY | Qualigen, Inc. | 2007-12-06 |
| K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC | Applied Dna Technologies, Inc. | 2007-06-29 |
| K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | Applied Dna Technologies, Inc. | 2007-06-29 |
Legacy Summary#
summary
FDA Review#
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