ANSH LABS, LLC

FDA Device Registration & Listing · Webster, TX, US · Registration 3008198807

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
3008198807
FEI Number
3008198807
Entity Name
ANSH LABS, LLC
City/State/Country
Webster, TX, US
Establishment Address
445 Medical Center Blvd, Webster, TX 77598, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ansh Labs, LLC (Owner Number: 10041690)
Owner / Operator Contact Address
445 Medical Center Blvd., Webster, TX 77598, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Glucagon AnshCheck Controls C-Peptide Prolactin Menocheck FSH

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JME Radioimmunoassay, Glucagon Clinical Chemistry Class 1 862.1335 2019-01-18
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-01-12
JKD Radioimmunoassay, C-Peptides Of Proinsulin Clinical Chemistry Class 1 862.1135 2019-01-18
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2021-01-25
QDH Menopause Test System Clinical Chemistry Class 2 862.1093 2018-12-26
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2019-01-18

Official Correspondent

Danielle Kempa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ansh Labs, 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
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04
K971921 Monobind PROLACTIN (PRL) HORMONE MICROPLATE ELISA 1997-06-24
K833852 Syncor Intl. Corp. FSH RIA 1984-01-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008198807. Last updated year: 2026. Please use registration number 3008198807 when referencing this establishment in official correspondence.
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