510(k) K042272 ยท KTN System, Test, Infectious Mononucleosis
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 28, 2005 |
| Received | Aug 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2016 | Alere San Diego, Inc. Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and se Terminated |
KTN | None listed |
| Jun 22, 2016 | Alere San Diego, Inc. Cardinal Health Mono Rapid Test, Catalog No. B1077-28,
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, Terminated |
KTN | None listed |
| Jun 22, 2016 | Alere San Diego, Inc. Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole Terminated |
KTN | None listed |
| Jun 22, 2016 | Alere San Diego, Inc. Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in w Terminated |
KTN | None listed |
| Jun 22, 2016 | Alere San Diego, Inc. Proadvantage Mono Rapid Test Cassette, Catalog No. P080016
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blo Terminated |
KTN | None listed |
| Jun 22, 2016 | Alere San Diego, Inc. Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in wh Terminated |
KTN | None listed |
| Jun 22, 2016 | Alere San Diego, Inc. Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whol Terminated |
KTN | None listed |
| Apr 18, 2013 | Alere San Diego, Inc. IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201
The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infecti Terminated |
KTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.