ALDEN MEDICAL LLC

FDA Device Registration & Listing · W Springfield, MA, US · Registration 1221361

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1221361
FEI Number
1221361
Entity Name
ALDEN MEDICAL LLC
City/State/Country
W Springfield, MA, US
Establishment Address
360 Cold Spring Ave, W Springfield, MA 01089, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ALDEN MEDICAL LLC (Owner Number: 9064620)
Owner / Operator Contact Address
360 COLD SPRING AVE., --, West Springfield, MA 01089, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Compliance Micro-X Peracidin PerAldecide Aldahol 1.8 Compat Metricide OPA Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2007-12-05
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2007-12-05
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2013-04-05
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2020-12-23
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2007-12-05
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2014-11-04

Official Correspondent

DAMON D'AMICO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALDEN MEDICAL LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033381 Discus Dental, Inc. DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL 2004-01-27
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21
K081789 Siemens Healthcare Diagnostics, Inc. DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR 2008-09-10
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221361. Last updated year: 2026. Please use registration number 1221361 when referencing this establishment in official correspondence.
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