Skip to content

Company · US

Tudor Laboratories, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1992. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DLJ	Calibrators, Drug Specific	3
JIS	Calibrator, Primary	1
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	1
LAN	Enzyme Immunoassay, N-Acetylprocainamide	1
LEG	Enzyme Immunoassay, Valproic Acid	1
LFM	Enzyme Immunoassay, Digitoxin	1
LFT	Fluorescent Immunoassay, Primidone	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 24, 1992	K921904	THYROXINE (FPIA) KIT Tudor Laboratories, Inc.	KLI
May 26, 1992	K921903	THYROXINE CALIBRATOR KIT Tudor Laboratories, Inc.	JIS
Sep 6, 1991	K913240	DIGITOXIN (FPIA) KIT Tudor Laboratories, Inc.	LFM
Oct 30, 1989	K895572	N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT Tudor Laboratories, Inc.	DLJ
Oct 25, 1989	K895571	N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT Tudor Laboratories, Inc.	LAN
Oct 20, 1989	K895567	PRIMIDONE (FPIA) KIT Tudor Laboratories, Inc.	LFT
Oct 3, 1989	K895569	VALPROIC ACID (FPIA) KIT Tudor Laboratories, Inc.	LEG
Sep 28, 1989	K895570	VALPROIC ACID (FPIA) CALIBRATOR KIT Tudor Laboratories, Inc.	DLJ
Sep 28, 1989	K895568	PRIMIDONE (FPIA) CALIBRATOR KIT Tudor Laboratories, Inc.	DLJ

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

Get alerts for these product codes