# K860812: Sickle Cell Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Michclone Associates, Inc.
- Decided: Apr 11, 1986 after 38 days
- Product code: GHM (Test, Sickle Cell)
- Device class: 2
- Regulation: 21 CFR 864.7825
- Recalls of this device: 3 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 23, 2012 · Not classified · Z-1503-2012: Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a smal
- Feb 23, 2012 · Not classified · Z-1501-2012: Michclone Associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from withi
- Feb 23, 2012 · Not classified · Z-1502-2012: Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a smal

Source page: https://510kreport.com/device/K860812
Methodology: https://510kreport.com/methodology