# K902154: NA Latex Myoglobin Test

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jun 1, 1990 after 17 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices 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.

## Most influential descendants
- K972513: Tinaquant Myoglobin Assay (1997), 4 descendants of its own
- K061683: Tina-Quant Myoglobin Gen.2 Test System (2006), 1 descendant of its own
- K983176: Elecsys Myoglobin Stat Assay (1998), 1 descendant of its own
- K973358: Myoglobin Control Set (1997), 1 descendant of its own
- K963292: Cobas Integra Reagent Cassettes & Ancillary Reagents (1996), 1 descendant of its own

Source page: https://510kreport.com/device/K902154
Methodology: https://510kreport.com/methodology