HOME ACCESS HEALTH CORP.

FDA Device Registration & Listing · Hoffman Est, IL, US · Registration 1423455

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
1423455
FEI Number
3000206414
Entity Name
HOME ACCESS HEALTH CORP.
City/State/Country
Hoffman Est, IL, US
Establishment Address
2401 Hassell Rd Ste 1510, Hoffman Est, IL 60169, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PWNHealth Chicago, LLC (Owner Number: 9031348)
Owner / Operator Contact Address
2401 W. HASSELL RD., SUITE 1510, Hoffman Estates, IL 60169, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

HomeAccess AiC Home Collection Home Collection OC Auto Micro FOB

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2015-03-17
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2015-03-17
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2002-02-20
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2008-12-02
OOX Automated Occult Blood Analyzer Hematology Class 2 864.6550 2011-10-03

Official Correspondent

Alison Mancusi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PWNHealth Chicago, 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
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K790947 Macomb Chemical Co. AUTO ENZYMATIC CHOLESTEROL 1979-06-28
K885023 Em Diagnostic Systems, Inc. CHOLESTEROL TEST ITEM NUMBER: SR1011 1989-02-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1423455. Last updated year: 2026. Please use registration number 1423455 when referencing this establishment in official correspondence.
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