# K972799: Dried Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Oct 10, 1997 after 74 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 its predicate without a number.
- (no number) NCCLS Frozen Meropenem Reference Panels: named in the summary without a submission number

## Indications for use
To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing * include: Viridaas group streptococci Although viridans streptocucci are indicated for testing® with the antimicrobial agent Meropenem, they are contraindicated for use with Meropenem on MicroScan Dried Gram-Positive MIC/Combo Panels.

Source page: https://510kreport.com/device/K972799
Methodology: https://510kreport.com/methodology