# K973662: Accu-Chek (R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage H Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 15, 1997 after 81 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930979 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930979: Accu-Chek Advantage Blood Glucose System, Boehringer Mannheim Corp. (1993) Summary page 1.
- K951887: Advantage Test Strips, Boehringer Mannheim Corp. (1995) Summary page 1.
- K954833: Accu-Chek Advantage Test Strips, Boehringer Mannheim Corp. (1996) Summary page 1.

## Recalls of this device
- Jun 22, 2006 · Not classified · Z-1364-06: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
- Jun 22, 2006 · Not classified · Z-1363-06: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.

## Indications for use
The Accu-Chek Complete System is intended for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.

Source page: https://510kreport.com/device/K973662
Methodology: https://510kreport.com/methodology