Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008773547

FEI Number

3008773547

Entity Name

BIO SB, INC.

City/State/Country

Santa Barbara, CA, US

Establishment Address

5385 Hollister Avenue, Bldg 8, #108, Santa Barbara, CA 93111, US

Establishment Type(s)

Remanufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Bio SB, Inc. (Owner Number: 10034698)

Owner / Operator Contact Address

5385 Hollister Avenue, Bldg 8, #108, Santa Barbara, CA 93111, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2011-01-04
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2010-12-22
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2010-12-22
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2010-12-22
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2013-08-13
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2010-12-22

Official Correspondent

Jessica Dunston

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bio SB, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008773547. Last updated year: 2026. Please use registration number 3008773547 when referencing this establishment in official correspondence.