510(k) K121397
- Device
- OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
- Applicant
- SEKISUI DIAGNOSTICS, LLC
- 510(k) number
- K121397
- Product code
- KHE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-28
- Date received
- 2012-05-09
- Regulation
- 864.6550
- Classification name
- Reagent, Occult Blood
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK STAVRO
- Address
- 6659 Top Gun St. San Diego CA US 92121 92121
FDA Registration Numbers#
- 2410251
- 2246703
- 3005360469
- 9710094
- 3021090658
- 3005610352
- 2087033
- 3007606081
- 3002792284
- 2030538
- 2014676
- 3005174594
- 3007301207
- 1618982
- 2025099
- 3022178699
- 1000369487
- 2060833
- 3005345870
- 1832216
- 2244821
- 1649661
- 3006621318
- 1123776
- 2250030
- 3011287770
- 3021186226
- 3015751263
- 3025041446
- 3043196750
- 3042471840
- 3002637618
- 1061932
- 1518939
- 3024753119
- 1017835
- 3008517993
- 3005984081
- 3009238284
- 2050010
- 9611917
- 3033751096
- 3003917514
- 1616487
- 3004635103
- 2024674
- 3033507883
- 9610126
- 2029372
- 3004569406
- 2030633
- 3030708766
- 3012516456
- 2435505
- 3017231634
- 1226769
- 3005311019
- 3023322455
- 2032839
Source Documents#
Other 510(k) Records For Product Code KHE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018-02-15 |
| K170548 | InSure ONE | Enterix, Inc. | 2017-10-05 |
| K171484 | hema-screen SPECIFIC Gold | Immunostics Inc., | 2017-06-14 |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Immunostics Inc., | 2017-01-17 |
| K143325 | OC-Light S FIT | Eiken Chemical Co., Ltd. | 2015-08-20 |
| K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST | Ind Diagnostics, Inc. | 2012-12-19 |
| K110309 | FOB ONE STEP RAPID TEST | Orient Gene Biotech | 2011-09-14 |
| K102664 | HEMA SCREEN ER | Immunostics Inc., | 2011-01-28 |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Ind Diagnostic, Inc. | 2010-07-19 |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Princeton BioMeditech Corp. | 2010-07-01 |
| K080812 | HEMOCCULT ICT | Beckman Coulter, Inc. | 2008-06-25 |
| K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS | Ameritek USA, Inc. | 2008-03-06 |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Alfa Scientific Designs, Inc. | 2007-06-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary