# K895880: Pancreatic a-Amylase Eps

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 19, 1989 after 75 days
- Product code: CIL (Cresol Red Colorimetry, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
0 of 23 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
- K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae (1998), 20 descendants of its own
- K003400: CRP HS Test System (2001), 12 descendants of its own
- K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) (2004), 7 descendants of its own
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set (2011), 3 descendants of its own
- K033185: Cobas Integra Alp Ifcc Gen.2 (2003), 3 descendants of its own

Source page: https://510kreport.com/device/K895880
Methodology: https://510kreport.com/methodology