# K964310: Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total Caliibration (Gem.C010)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Nov 27, 1996 after 29 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 6, 2015 · Class III · Z-1707-2015: The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
- Mar 28, 2006 · Not classified · Z-0765-06: Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when use
- Jan 10, 2003 · Not classified · Z-0558-03: Label printing irregularities on cartons and/or bottles.

Source page: https://510kreport.com/device/K964310
Methodology: https://510kreport.com/methodology