# K983584: Human Serum Albumin (Hsa)

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Feb 8, 1999 after 118 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- 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. The FDA summary names no predicate by number.

## Indications for use
Human Serum Albumin (HSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular, HSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.

Source page: https://510kreport.com/device/K983584
Methodology: https://510kreport.com/methodology