# K081896: Biogenics Bioquad 4-Well Ivf Culture Dish

- Pathway: 510(k) (Traditional)
- Applicant: Biogenics, Inc.
- Decided: Aug 20, 2008 after 48 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware Intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques or cell culture.

Source page: https://510kreport.com/device/K081896
Methodology: https://510kreport.com/methodology