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

Annotate this Case

U.S. Supreme Court

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

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. 394 U. S. 791-801.

392 F.2d 21, reversed.

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