LIBClass I

Device, General Purpose, Microbiology, Diagnostic

21 CFR 866.2660 / Microbiology

LIB is the FDA product code for Device, General Purpose, Microbiology, Diagnostic, a class I device type, regulated under 21 CFR 866.2660. As of 2026-09-10, FDA records hold 43 510(k) clearances under this code, the most recent dated 2003-01-29, and 13 recalls.

Classification record

Product code: LIB
Device name: Device, General Purpose, Microbiology, Diagnostic
Regulation: 21 CFR 866.2660
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 43
Ingested recalls: 13

Clearances, product code LIB

By decision year

43 clearances under product code LIB with a decision year between 1981 and 2003, 1983 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code LIB by decision year
Year	Clearances
1981	1
1982	8
1983	10
1984	6
1985	10
1986	2
1987	3
1991	1
1992	1
2003	1

Applicants with the most clearances

Product code LIB

Applicants holding the most 510(k) clearances under product code LIB
Applicant	Clearances
Dynatech Corp.	10
bioMerieux, Inc.	4
Corning Medical & Scientific	3
Plastic Injectors, Inc.	3
Portable Medical Laboratories, Inc.	3
American Dade	2
Carr-Scarborough Microbiologicals, Inc.	2
Microtech Medical Systems, Inc.	2
Abco Dealers, Inc.	1
Behring Diagnostics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order