SALIMETRICS LLC.

FDA Device Registration & Listing · State College, PA, US · Registration 3003760091

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
3003760091
FEI Number
3003760091
Entity Name
SALIMETRICS LLC.
City/State/Country
State College, PA, US
Establishment Address
101 INNOVATION BLVD STE 302, State College, PA 16803, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
SALIMETRICS LLC. (Owner Number: 9045886)
Owner / Operator Contact Address
101 INNOVATION BLVD., STE. 302, --, State College, PA 16803, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K031348
PMA Number
N/A

All Registered Proprietary Names

Swab Storage Tube Saliva Collection Aid (SCA) Saliva Collection Aid 96 Well Format CRYOVIAL Salimetrics Salivary Insulin ELISA Kit Salivary Progesterone Enzyme Immunoassay kit Expanded Range High Sensitivity Salivary Cortisol Enzyme immunoassay Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2006-09-05
CFP Radioimmunoassay, Immunoreactive Insulin Clinical Chemistry Class 1 862.1405 2024-05-23
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2005-08-29
NHG Enzyme Immunoassay, Cortisol, Salivary Clinical Chemistry Class 2 862.1205 2007-11-08

Official Correspondent

Mark Hollerbach

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SALIMETRICS LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003760091. Last updated year: 2026. Please use registration number 3003760091 when referencing this establishment in official correspondence.
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