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