510(k) K181436
- Device
- OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
- Applicant
- Sekisui Diagnostics, LLC
- 510(k) number
- K181436
- Product code
- KTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-22
- Date received
- 2018-06-01
- Regulation
- 866.5640
- Classification name
- System, Test, Infectious Mononucleosis
- Medical specialty
- Immunology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shelly Harris
- Address
- 6659 Top Gun St. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3004043187
- 1061932
- 1616487
- 3002792284
- 1832216
- 3012494290
- 1641328
- 2250030
- 2000007960
- 2029372
- 2435505
- 3033507883
- 9610746
- 1649661
- 2030538
- 1924669
- 2030633
- 3003750284
- 1524213
- 2244821
- 3017772438
- 3003917514
- 2246703
- 2915274
- 3032705
Source Documents#
Other 510(k) Records For Product Code KTN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | ACON Laboratories, Inc. | 2005-02-28 |
| K030215 | BIORAPID MONONUCLEOSIS | Instrumentation Laboratory CO | 2003-02-24 |
| K012901 | COLOR-MONOGEN | Instrumentation Laboratory CO | 2001-09-27 |
| K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | Oxoid , Ltd. | 1999-01-28 |
| K981946 | CLEARVIEW IM | Unipath , Ltd. | 1998-12-10 |
| K972457 | MONOCOL/LEX-IM TEST | Immunostics Inc., | 1997-12-01 |
| K972231 | OSOM MONO TEST 143 | Wyntek Diagnostics, Inc. | 1997-08-26 |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | Genzyme Diagnostics | 1997-02-25 |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | Princeton BioMeditech Corp. | 1997-02-04 |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-24 |
| K930778 | IMMUNOCARD MONO | Meridian Diagnostics, Inc. | 1993-12-27 |
| K932688 | EYE SPOT IM TEST | J.S. Medical Assoc. | 1993-09-08 |
| K932551 | ACCUTEX IM LATEX TEST | J.S. Medical Assoc. | 1993-08-09 |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | Princeton Biomedix | 1993-02-23 |
| K924037 | ACCUTEX IM RBC TEST | J.S. Medical Assoc. | 1992-11-02 |
Legacy Summary#
summary
FDA Review#
Decision Summary