United States v. Bacto-Unidisk, 394 U.S. 784 (1969)

United States v. An Article of Drug . . . Bacto-Unidisk


No. 343


Argued January 23, 1969
Decided April 28, 1969
394 U.S. 784

CERTIORARI TO THE UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT

Syllabus

Antibiotic sensitivity disc used as laboratory screening test to help determine proper antibiotic drug to administer to patients held not merely a "device" but a "drug" within definition of § 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, and thus subject to pre-market clearance regulations issued pursuant to § 507 of the Act. Pp. 791-801.

392 F.2d 21, reversed.