Medical Device Manufacturer · US , Dallas , TX

Tudor Laboratories, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1989

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tudor Laboratories, Inc. Toxicology ✕

7 devices

1-7 of 7

Cleared Sep 06, 1991

DIGITOXIN (FPIA) KIT

Toxicology · 46d

Cleared Oct 30, 1989

N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT

Toxicology · 54d

Cleared Oct 25, 1989

N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT

Toxicology · 49d

Cleared Oct 20, 1989

PRIMIDONE (FPIA) KIT

Toxicology · 44d

Cleared Oct 03, 1989

VALPROIC ACID (FPIA) KIT

Toxicology · 27d

Cleared Sep 28, 1989

PRIMIDONE (FPIA) CALIBRATOR KIT

Toxicology · 22d

Cleared Sep 28, 1989

VALPROIC ACID (FPIA) CALIBRATOR KIT

Toxicology · 22d