Ultrasonic Diagnostic System, Mod. 202

FDA 510(k) K800364 · Hoffrel Instruments, Inc.

Substantially Equivalent

510(k) numberK800364

Submission

Device name
Ultrasonic Diagnostic System, Mod. 202
Applicant
Hoffrel Instruments, Inc.
Mchenry, IL, US
Received
February 20, 1980
Decision date
March 12, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DKX – Thin Layer Chromatography, Barbiturate
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3150
Specialty
Clinical Toxicology

Other 510(k)s with product code DKX

510(k)DeviceApplicantDecision
K030211Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016DKX · Traditional Icn Biomedicals, Inc.06/13/2003SE

More from Icn Biomedicals, Inc.

510(k)DeviceDecision
K870850Mod 482JOP · Traditional 09/08/1987SE
K860235Mod 426, Medical Ultrasonic Diagnostc TransducerITX · Traditional 05/15/1986SE
K850165Motor Drive, Mechanical Sector SCANNING-MOD417JOP · Traditional 10/23/1985SE
K844916Model 518 & 519 Ultrasonoscope W/DopplerIYO · Traditional 04/22/1985SE
K834277Mod 427IYO · Traditional 02/17/1984SE
K834276Mod 456IYO · Traditional 02/17/1984SE
K837282Model VPS Vascular Profile System · Traditional 04/26/1983SE
K837229Transducer Models 450, 451, 452, 453, 454 · Traditional 04/15/1983SE
K837142Transducers Models 421, 419 and 420 for Irex System · Traditional 03/23/1983SE
K790396Ultrasonic Diagnostic SystemIYO · Traditional 03/21/1979SE

Questions and answers

When was Ultrasonic Diagnostic System, Mod. 202 cleared by the FDA?

Ultrasonic Diagnostic System, Mod. 202 (K800364) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 21 days after the submission was received.

What is the product code of K800364?

The FDA product code is DKX – Thin Layer Chromatography, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.