Company ยท US
Nichols Institute Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2005. Name variants (Inc, Corp, punctuation) are merged.
68510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | 16 |
| CFL | Radioimmunoassay, Human Growth Hormone | 5 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 |
| CKG | Radioimmunoassay, Acth | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 4 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 3 |
| CGR | Radioimmunoassay, Cortisol | 3 |
| DHA | System, Test, Human Chorionic Gonadotropin | 3 |
| JKR | Radioimmunoassay, Calcitonin | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 2 |
| CJM | Radioimmunoassay, Aldosterone | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| GGT | Assay, Erythropoietin | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| MSW | System, Test, Thyroglobulin | 2 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| DGO | Ige, Peroxidase, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2005 | K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY Nichols Institute Diagnostics | CJM |
| Dec 17, 2004 | K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY Nichols Institute Diagnostics | DHA |
| Dec 9, 2004 | K042689 | NICHOLS ADVANTAGE CORTISOL Nichols Institute Diagnostics | CGR |
| Jun 8, 2004 | K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 Nichols Institute Diagnostics | CEW |
| Apr 22, 2004 | K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY Nichols Institute Diagnostics | CEW |
| Jan 26, 2004 | K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 Nichols Institute Diagnostics | CEW |
| Jul 31, 2003 | K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY Nichols Institute Diagnostics | CJM |
| Oct 25, 2002 | K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY Nichols Institute Diagnostics | LYR |
| Oct 9, 2002 | K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) Nichols Institute Diagnostics | CEW |
| Dec 13, 2001 | K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY Nichols Institute Diagnostics | CEW |
| Oct 9, 2001 | K012367 | VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D Nichols Institute Diagnostics | JIT |
| Sep 6, 2001 | K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) Nichols Institute Diagnostics | CIB |
| Oct 20, 2000 | K002888 | NICHOLS ADVANTAGE THYROGLOB Nichols Institute Diagnostics | MSW |
| May 9, 2000 | K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 Nichols Institute Diagnostics | MSW |
| Dec 6, 1999 | K992188 | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 Nichols Institute Diagnostics | JNM |
| Mar 23, 1999 | K980737 | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY Nichols Institute Diagnostics | GGT |
| Feb 5, 1999 | K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 Nichols Institute Diagnostics | CGR |
| Feb 2, 1999 | K984186 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY Nichols Institute Diagnostics | DBF |
| Jan 26, 1999 | K983992 | NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY Nichols Institute Diagnostics | JZO |
| Oct 16, 1998 | K982866 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 Nichols Institute Diagnostics | JZO |
| Apr 3, 1998 | K980716 | ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY Nichols Institute Diagnostics | LTJ |
| Jun 26, 1997 | K972070 | NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS Nichols Institute Diagnostics | JJY |
| May 21, 1997 | K964635 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT Nichols Institute Diagnostics | JKR |
| Apr 8, 1997 | K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT Nichols Institute Diagnostics | CGR |
| Mar 28, 1997 | K962687 | GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM Nichols Institute Diagnostics | JQW |
| Mar 18, 1997 | K962408 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT Nichols Institute Diagnostics | CEC |
| Mar 11, 1997 | K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT Nichols Institute Diagnostics | CDP |
| Feb 18, 1997 | K961142 | STRATEC LIA II ANALYZER Nichols Institute Diagnostics | JJE |
| Dec 24, 1996 | K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE Nichols Institute Diagnostics | CKG |
| Dec 10, 1996 | K962598 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT Nichols Institute Diagnostics | CEW |
| Sep 27, 1996 | K962033 | CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT Nichols Institute Diagnostics | CEW |
| Jul 16, 1996 | K961650 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT Nichols Institute Diagnostics | JLW |
| Jul 8, 1996 | K961678 | HUMAN GROWTH HORMONE IMMUNOASSAY KIT Nichols Institute Diagnostics | CFL |
| Nov 20, 1995 | K945961 | CALCITONIN IMMUNOASSAY KIT Nichols Institute Diagnostics | JKR |
| Nov 3, 1995 | K954418 | INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) Nichols Institute Diagnostics | CEW |
| Aug 2, 1995 | K950029 | 5STRATEC SL 300 LIA-MAT Nichols Institute Diagnostics | JJQ |
| May 2, 1995 | K950921 | CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY Nichols Institute Diagnostics | JLW |
| Apr 5, 1995 | K935319 | CHEMILUMINESCENCE LH Nichols Institute Diagnostics | CEP |
| Nov 17, 1993 | K926220 | T3 UPTAKE CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics | KHQ |
| Jan 6, 1993 | K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY Nichols Institute Diagnostics | CIB |
| Dec 23, 1992 | K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics | MSJ |
| Sep 2, 1992 | K923015 | TOTAL T3 CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics | CDP |
| Jan 19, 1990 | K896808 | IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I Nichols Institute Diagnostics | CFL |
| Nov 17, 1989 | K896222 | FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics | CEC |
| Aug 30, 1988 | K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES Nichols Institute Diagnostics | CKG |
| Apr 28, 1988 | K881123 | ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. Nichols Institute Diagnostics | CGJ |
| Apr 18, 1988 | K881124 | ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY Nichols Institute Diagnostics | CEP |
| Dec 2, 1987 | K874572 | ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM Nichols Institute Diagnostics | DBF |
| Sep 2, 1987 | K872390 | ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM Nichols Institute Diagnostics | JHI |
| Oct 16, 1986 | K863679 | ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM Nichols Institute Diagnostics | CEP |
Newest 50 of 68.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2005 | Nichols Institute Diagnostics Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512 Terminated |
GGT | None listed |
| Oct 15, 2005 | Nichols Institute Diagnostics Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045. Terminated |
CEW | None listed |
| Oct 6, 2005 | Nichols Institute Diagnostics Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039) Terminated |
DHA | K042676 |
| Oct 6, 2005 | Nichols Institute Diagnostics Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052) Terminated |
DHA | None listed |
| Jul 28, 2005 | Nichols Institute Diagnostics Nichols Advantage ACTH Test System, catalog number 62-7004. Terminated |
CKG | K962601 |
| Jun 4, 2005 | Nichols Institute Diagnostics Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756) Terminated |
CFL | None listed |
| May 10, 2005 | Nichols Institute Diagnostics Bio-Intact PTH (1-84) Assay,
Catalog No. 62-7040 Terminated |
CEW | K033727 |
| May 10, 2005 | Nichols Institute Diagnostics Nichols IRMA Intact PTH Assay, catalog No. 40-2171 Terminated |
CEW | K861797 |
| Apr 28, 2005 | Nichols Institute Diagnostics Nichols Advantage TSH - Third Generation Terminated |
JLW | None listed |
| Feb 24, 2005 | Nichols Institute Diagnostics Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. Terminated |
MRG | K012367 |