Neometrics, Inc.
E. Northport, NY, US
Neometrics, Inc. appears in FDA device records in E. Northport, NY. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Neometrics, Inc. between 1978 and 2015. The busiest year on record is 2015, with 3. The most recent is 2015, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1984 | 1 |
| 1990 | 1 |
| 1995 | 1 |
| 1997 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152560 | Bard Snare Retrieval Kit | MMX | Substantially Equivalent | |
| K150225 | NovaGold High Performance Guidewire | OCY | Substantially Equivalent | |
| K143135 | Spring Coil Guidewire | DQX | Substantially Equivalent | |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | OCY | Substantially Equivalent | |
| K123439 | NEO ERCP GUIDEWIRE | OCY | Substantially Equivalent | |
| K101729 | NEOWIRE PTA/PTCA GUIDEWIRE | DQX | Substantially Equivalent | |
| K070150 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | |
| K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | |
| K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | DQX | Substantially Equivalent | |
| K033321 | SELECTIVA SB GUIDEWIRE | DQX | Substantially Equivalent | |
| K031652 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | |
| K012861 | VASCUPUNCTURE ACCESS WIRE | DQX | Substantially Equivalent | |
| K013024 | SELECTIVA GUIDEWIRE | DQX | Substantially Equivalent | |
| K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | JLW | Substantially Equivalent | |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | JIA | Substantially Equivalent | |
| K974047 | ACCUWELL PHENYLALANINE ASSAY | JNB | Substantially Equivalent | |
| K972974 | ACCUWELL T4-EIA | KLI | Substantially Equivalent | |
| K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE | JLX | Substantially Equivalent | |
| K901939 | NEOCOAT T4 | CDX | Substantially Equivalent | |
| K843281 | ACCUSCREEN TSH | JLW | Substantially Equivalent | |
| K781222 | ACCUSCREEN T4 | CDX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MMXDevice, Percutaneous Retrieval
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- JIAEnzymatic Methods, Galactose
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain