Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2018685

FEI Number

2018685

Entity Name

BIO-ANALYSIS, INC.

City/State/Country

Santa Monica, CA, US

Establishment Address

1701 BERKELEY ST., Santa Monica, CA 90404, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO-ANALYSIS, INC. (Owner Number: 2018685)

Owner / Operator Contact Address

1701 BERKELEY ST., --, Santa Monica, CA 90404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133303

PMA Number

N/A

All Registered Proprietary Names

Pantex AM/PM Salivary Cortisol Enzyme Immunoassay Pantex Salivary Direct Testosterone Enzyme Immunoassay (EIA) Kit, Pantex Sample Collection Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHG	Enzyme Immunoassay, Cortisol, Salivary	Clinical Chemistry	Class 2	862.1205	2012-06-25
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2014-12-03
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2014-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIO-ANALYSIS, INC.

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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2018685. Last updated year: 2026. Please use registration number 2018685 when referencing this establishment in official correspondence.