FDA 510(k) Applications Submitted by Immunostics, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K163225 |
11/17/2016 |
AFIAS iFOB with AFIAS-50 |
IMMUNOSTICS, INC. |
| K163465 |
12/12/2016 |
hemochroma PLUS System |
IMMUNOSTICS, INC. |
| K163554 |
12/19/2016 |
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test |
Immunostics, Inc. |
| K972456 |
07/01/1997 |
RHEUMACOL RHEUMATOID FACTOR TEST |
IMMUNOSTICS, INC. |
| K972457 |
07/01/1997 |
MONOCOL/LEX-IM TEST |
IMMUNOSTICS, INC. |
| K972606 |
07/11/1997 |
PREGNACOL PREGNANCY TEST |
IMMUNOSTICS, INC. |
| K171484 |
05/22/2017 |
hema-screen SPECIFIC Gold |
Immunostics, Inc. |
| K060463 |
02/22/2006 |
HEMA SCREEN SPECIFIC IFOBT |
IMMUNOSTICS, INC. |
| K031490 |
05/12/2003 |
RUBELLACOL |
IMMUNOSTICS, INC. |
| K041728 |
06/25/2004 |
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE |
IMMUNOSTICS, INC. |
| K182298 |
08/24/2018 |
hemochroma PLUS System |
Immunostics, Inc. |
| K102664 |
09/15/2010 |
HEMA SCREEN ER |
IMMUNOSTICS, INC. |
| K992759 |
08/17/1999 |
COLON ALERT TEST |
IMMUNOSTICS, INC. |
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