Data / Medical devices / United States / F.M. Howell & Co.
F.M. Howell & Co.: FDA-registered device maker in Elmira, NY, United States, 10 510(k) clearances
F.M. Howell & Co. is registered with the FDA (registration 1313700) in Elmira, NY, United States. It lists 16 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 1, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1313700
- Address
- 151 East Fifth ST., P.O. Box 286, Elmira, NY, United States, 14902
- Owner or operator
- F.M. HOWELL & CO. (1313700)
- Roles
- Repackager or relabeler
- First device listed
- November 18, 2004
- Registered through
- 2026
- Brand names listed
- BD PRECISION GLIDE NEEDLE, BIOJECT VIAL ADAPTER, BinaxNOW COVID-19 Ag Card HOME TEST, Clearblue Visual Pouched Preg Stick; Clearblue Rapid Detection Pregnancy Test, Conceptrol, Dollar General Preg One Step Cassette; First Signal Pregnancy Cassette; Walmart First Signal Preg Cassette, EMERALD STERILE GAUZE PAD, EXACTA-MED ORAL DISPENSER and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 1, 2018 | K180045 | Omnipod DASH Insulin Management System | LZG | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| May 12, 2011 | K110433 | CLEARBLUE EASY PREGNANCY TEST | LCX | Substantially Equivalent | SPD Development Company Limited | accessdata.fda.gov |
| July 18, 2006 | K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| August 7, 2001 | K012215 | QUIK-CHECK HOME PREGNANCY TEST | LCX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| June 14, 1999 | K990877 | HISTOFREEZER DEVICE | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| March 4, 1999 | K984017 | ALLISON MEDICAL INSULIN SYRINGE (AMIS) | FMF | Substantially Equivalent | Allison Medical, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984079 | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST | JHI | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | LCX | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 12, 1989 | K891726 | VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) | LYZ | Substantially Equivalent | Baldur Systems Corp. | accessdata.fda.gov |
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Updated June 1, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.