Data / Medical devices / United States / CalibreScientific US, Inc.

CalibreScientific US, Inc.: FDA-registered device maker in Vancouver, WA, United States, 15 510(k) clearances

Name: CalibreScientific US, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CalibreScientific US, Inc. is registered with the FDA (registration 2025606) in Vancouver, WA, United States. It lists 32 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 12, 2006. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2025606
Address: 1311 Se Cardinal Ct Ste 170, Vancouver, WA, United States, 98683
Owner or operator: CalibreScientific US, Inc. (2025606)
Roles: Manufacturer
First device listed: November 19, 2001
Registered through: 2026
Brand names listed: 0.2% Bovine Albumin Fraction V Solu, AFB Stain QC Slides, Auramine O, CELL-BOND(TM), CONSED RED(TM), CONSED(TM), Carbol PRO-Clear(TM), Carbol-Xylene and more

Devices it lists

Device	Product code	Class	Role	Source
Acridine Orange	IDC	1	Manufacturer	accessdata.fda.gov
Adhesive, Albumin-Based	KEL	1	Manufacturer	accessdata.fda.gov
Agent, Clearing	KEM	1	Manufacturer	accessdata.fda.gov
Aniline Blue	KFD	1	Manufacturer	accessdata.fda.gov
Auramine O	KJK	1	Manufacturer	accessdata.fda.gov
Brilliant Green	KJO	1	Manufacturer	accessdata.fda.gov
Carbol Fuchsin	ICL	1	Manufacturer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Manufacturer	accessdata.fda.gov
Culture Media, Selective And Non-Differential	JSJ	1	Manufacturer	accessdata.fda.gov
Device, Parasite Concentration	LKS	1	Manufacturer	accessdata.fda.gov
Fixative, Alcohol Containing	LDZ	1	Manufacturer	accessdata.fda.gov
Formalin, Neutral Buffered	IFP	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Giemsa Stain	HYF	1	Manufacturer	accessdata.fda.gov
Hematoxylin	HYJ	1	Manufacturer	accessdata.fda.gov
Kit, Identification, Mycobacteria	JSY	1	Manufacturer	accessdata.fda.gov
Material, Quality Control, Semen Analysis	NRF	2	Manufacturer	accessdata.fda.gov
Ph Buffer	JCC	1	Manufacturer	accessdata.fda.gov
Quality Control Slides	LJG	1	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
Slides, Microscope	KEW	1	Manufacturer	accessdata.fda.gov
Solution, Formalin-Sodium Acetate	IGB	1	Manufacturer	accessdata.fda.gov
Sperm, Antigen, Antiserum, Control	DFQ	1	Manufacturer	accessdata.fda.gov
Stains, Chemical Solution	LED	1	Manufacturer	accessdata.fda.gov
Stains, Microbiologic	JTS	1	Manufacturer	accessdata.fda.gov
Sudan Iii	KKJ	1	Manufacturer	accessdata.fda.gov
Sudan Iv	KKK	1	Manufacturer	accessdata.fda.gov
Supplement, Culture Media	JSK	1	Manufacturer	accessdata.fda.gov
Test, Leukocyte Peroxidase	GIA	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 12, 2006	K053257	PARA-PRO FC50	LKS	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
July 25, 1989	K894045	MODIFIED POLYCHROME IV STAIN	KFD	Substantially Equivalent	Devetec, Inc.	accessdata.fda.gov
January 24, 1989	K890148	ATS TB RAPID STAIN SET PRODUCT #034-45	ICL	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
January 10, 1989	K890022	ATS MAYER'S ALBUMIN	KEL	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
May 25, 1988	K881949	ATS NAC-PAC SET	JSK	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
May 13, 1988	K881879	ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42	JSK	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
May 13, 1988	K881698	ATS PVA FIXATIVE SOLUTION	LDZ	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
May 13, 1988	K880989	ATS CRYPTOSPORIDIUM STAIN SET	JTS	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
March 30, 1988	K881042	ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)	JTS	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
March 30, 1988	K880962	ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES	LJG	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
March 24, 1988	K880990	ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION	JSY	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
October 31, 1985	K854176	POLYCHROME IV STAIN	LED	Substantially Equivalent	Devetec, Inc.	accessdata.fda.gov
January 7, 1983	K823706	ATS AFB STAIN CONTROL SLIDE	LJG	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
January 7, 1983	K823705	ATS PARASITOLOGY STAIN CONTROL SLIDE	LJG	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov
January 7, 1983	K823704	ATS GRAM STAIN CONTROL SLIDE	LJG	Substantially Equivalent	Alpha-Tec Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 12, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.