Company ยท US
Lab Vision Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2006. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | 9 |
| MVU | Reagents, Specific, Analyte | 1 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 1 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 1 |
| NTR | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2016 | Lab Vision Corporation CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each.
Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amou Terminated |
NJT | None listed |
| Oct 27, 2015 | Lab Vision Corporation Thermo Scientific p21 WF1 Ab-3 (DCS-60.2)
1 ml (0.4mg/ml):
Product code: MS-230-P and MS-230P0;
Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by w Terminated |
NTR | None listed |
| Jan 16, 2014 | Lab Vision Corporation Estrogen Receptor AB-11 (Clone ID5)
Mouse Monoclonal Antibody
1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA
Thermo Fisher Scientific
Anatomical Pathology
Tudor Rd., Manor Park
R Terminated |
MVU | None listed |
| Feb 22, 2012 | Lab Vision Corporation Streptavidin Alkaline Phosphatase (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect specific antibodies bound to an an Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Detection System;
Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect speci Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Plus Large Volume Detection System;
Anti-Polyvalent, Alk-Phos (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Large Volume Detection System;
Anti-Polyvalent, Alk-Phos (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Plus Detection System;
Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detec Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Detection System;
Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect spe Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Detection System;
Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect spe Terminated |
NJT | None listed |
| Sep 15, 2010 | Lab Vision Corporation NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of Terminated |
NJT | None listed |