FDA product code LIB: Device, General Purpose, Microbiology, Diagnostic
LIB is the FDA product code for device, general purpose, microbiology, diagnostic. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 43 510(k) submissions under LIB, from 22 different applicants. The average 510(k) review took 46 days (median 35). FDA has posted 13 recalls for LIB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LIB clearance
Top LIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynatech Corp. | 10 | 1985-12-06 |
| Organon Teknika Corp. | 4 | 1983-08-11 |
| Corning Medical & Scientific | 3 | 1987-07-07 |
| Portable Medical Laboratories, Inc. | 3 | 1985-03-13 |
| Plastic Injectors, Inc. | 3 | 1984-05-25 |
17 more applicants have LIB clearances. See the full list in Caduvo.
Most recent LIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023677 | Osmetech | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | 2003-01-29 | 89 |
| K920416 | Behring Diagnostics, Inc. | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB | 1992-04-08 | 68 |
| K912558 | Gull Laboratories, Inc. | GULL ELISAWARE | 1991-09-16 | 97 |
| K872273 | Corning Medical & Scientific | CORNING EASY WASH ELISA PLATES | 1987-07-07 | 22 |
| K871559 | Corning Costar Corp. | CELL LIFTER | 1987-05-15 | 23 |
Recalls for LIB devices
13 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-23.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LIB?
LIB is the FDA product code for device, general purpose, microbiology, diagnostic. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LIB?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LIB?
Across 43 cleared submissions the average was 46 days from receipt to decision (median 35).
Which companies have the most LIB clearances?
Dynatech Corp. (10); Organon Teknika Corp. (4); Corning Medical & Scientific (3); Portable Medical Laboratories, Inc. (3); Plastic Injectors, Inc. (3).
Have LIB devices been recalled?
Yes: 13 product recalls across 7 recall events; the most recent began 2025-10-23.
Next steps
- Run an FDA pathway report with predicate devices for product code LIB
- Run a recall and safety report across every LIB manufacturer
- Watch product code LIB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times