Company ยท US
Genzyme Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2010. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 4 |
| JFJ | Catalytic Methods, Amylase | 4 |
| FTL | Mesh, Surgical, Polymeric | 3 |
| LBR | Ldl & Vldl Precipitation, Hdl | 3 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 3 |
| MRR | System, Test, Low Density, Lipoprotein | 3 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 3 |
| GGT | Assay, Erythropoietin | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| MCN | Barrier, Absorbable, Adhesion | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| FTM | Mesh, Surgical | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JIT | Calibrator, Secondary | 1 |
| JWZ | Kit, Screening, Trichomonas | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 |
| LRO | General Surgery Tray | 1 |
| LYA | Splint, Intranasal Septal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2010 | K102242 | OSOM C. DIFFICILE TOXIN A/B TEST Genzyme Corporation | LLH |
| Sep 25, 2009 | K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 Genzyme Corporation | PSZ |
| May 15, 2008 | K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR Genzyme Corporation | NDY |
| Jan 17, 2007 | K063739 | SEPRAMESH, MODEL 5959-1214 Genzyme Corporation | FTL |
| Jun 12, 2006 | K061508 | OSOM INFLUENZA A&B TEST Genzyme Corp. | PSZ |
| Feb 21, 2006 | K051244 | GENZYME OSOM INFLUENZA A & B TEST Genzyme Corp. | PSZ |
| Dec 19, 2005 | K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH Genzyme Corporation | FTL |
| Jul 11, 2005 | K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT Genzyme Corporation | KHJ |
| Jun 25, 2004 | K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET Genzyme Corp. | DCK |
| Jun 4, 2004 | K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH Genzyme Corp. | FTM |
| Apr 2, 2004 | K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST Genzyme Corp. | JWZ |
| Jan 16, 2003 | K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST Genzyme Corp. | JHI |
| Jul 25, 2002 | K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR Genzyme Corp. | LBS |
| Jun 18, 2002 | K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE Genzyme Corp. | GAT |
| Oct 30, 2001 | K012532 | SEPRAGEL SINUS Genzyme Corp. | LYA |
| Aug 10, 2001 | K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT Genzyme Corp. | JFJ |
| Mar 21, 2000 | K000239 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL Genzyme Corp. | LCP |
| Mar 2, 2000 | K994328 | SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX Genzyme Corp. | FTL |
| Oct 18, 1999 | K992766 | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET Genzyme Corp. | MRR |
| Oct 4, 1999 | K993132 | GENZYME DIRECT AMYLASE VERIFIER Genzyme Corp. | JIT |
| Nov 25, 1998 | K983726 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL Genzyme Corp. | LCP |
| Jun 18, 1997 | K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET Genzyme Corp. | LBR |
| Jun 16, 1997 | K971190 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR Genzyme Corp. | LBS |
| Jun 16, 1997 | K971162 | LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR Genzyme Corp. | LBS |
| Aug 19, 1996 | K962186 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR Genzyme Corp. | LBR |
| Feb 5, 1996 | K954898 | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) Genzyme Corp. | GGT |
| Mar 15, 1995 | K943150 | DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT Genzyme Corp. | MRR |
| Oct 28, 1993 | K933397 | GENZYME A-AMYLASE TEST REAGENT Genzyme Corp. | JFJ |
| Jun 25, 1993 | K926390 | PREDICTA ERYTHROPOIETIN KIT Genzyme Corp. | GGT |
| Jan 6, 1993 | K924674 | DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT Genzyme Corp. | MRR |
| Mar 27, 1992 | K921057 | AMYLASE REAGENT Genzyme Corp. | JFJ |
| Jul 1, 1991 | K912519 | AMYLASE REAGENT Genzyme Corp. | JFJ |
| May 22, 1991 | K911406 | HDL CHOLESTEROL REAGENT Genzyme Corp. | LBR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2012 | Genzyme Corporation seprafilm Single Site ADHESION BARRIER
Re-order Number: 6641-01
Product Usage:
Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct inte Terminated |
MCN | None listed |
| Jun 21, 2012 | Genzyme Corporation seprafilm Procedure Pack ADHESION BARRIER
Re-order Number: 5086-02
Product Usage:
Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct Terminated |
MCN | None listed |
| Aug 28, 2010 | Genzyme Corporation Genzyme Biosurgery Essentials Kit, Item Number 82004 Terminated |
LRO | None listed |
| Aug 24, 2008 | Genzyme Corporation Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only
Product Number: 4301-05 Terminated |
None listed | |
| Aug 24, 2008 | Genzyme Corporation Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier)
Product Number: 4301-02 Terminated |
None listed | |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-E
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | K897150 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-D
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | K897150 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-C
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | K897150 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-B
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01. Terminated |
CHI | K897150 |