Data / Medical devices / Germany / Ibl International GMBH

Ibl International GMBH: FDA-registered device maker in Hamburg, Germany, 4 510(k) clearances

Name: Ibl International GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ibl International GMBH is registered with the FDA (registration 9710337) in Hamburg, Germany. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 25, 2015. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9710337
FEI number: 3002676602
Address: Flughafenstrasse, 52a, Hamburg, Germany, 22335
Owner or operator: Tecan Group AG (9050992)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: February 23, 2005
Registered through: 2027
Brand names listed: 17-OH-Progesterone ELISA (30223011), 17beta-Estradiol Saliva Luminescence Immunoassay, 96PW, Acetylcholine Receptor Autoantibodies (ARAb) RRA, Anti-Muellerian Hormone (AMH) ELISA, CA 72-4 ELISA, CALIBRATOR SET IMMUNOSUPPRESANTS RUO, CALIBRATOR SET LC-MS PSYCHOT.MED. 1 RUO and more

Devices it lists

Device	Product code	Class	Role	Source
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	NST	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cortisol, Salivary	NHG	2	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Research Use Only/Immunology Devices	OTR	N	Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	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
November 25, 2015	K150528	Cortisol Saliva Luminescence Immunoassay	NHG	Substantially Equivalent	Ibl International GmbH	accessdata.fda.gov
November 18, 2005	K051144	ACETYLCHOLINE RECEPTOR AB (ARAB)RRA	NST	Substantially Equivalent	Ibl-Hamburg GmbH	accessdata.fda.gov
July 22, 2004	K040923	LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA	JLS	Substantially Equivalent	Ibl GmbH	accessdata.fda.gov
February 27, 2004	K033786	LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA	JIT	Substantially Equivalent	Ibl GmbH	accessdata.fda.gov

Compare with other makers

Updated November 25, 2015. 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.