Pancreatic A-Amylase Eps
FDA 510(k) K895880 · Boehringer Mannheim Corp.
510(k) numberK895880
Submission
- Device name
- Pancreatic A-Amylase Eps
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- October 5, 1989
- Decision date
- December 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIL – Cresol Red Colorimetry, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIL
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Questions and answers
When was Pancreatic A-Amylase Eps cleared by the FDA?
Pancreatic A-Amylase Eps (K895880) received a 510(k) decision of Substantially Equivalent on December 19, 1989, 75 days after the submission was received.
What is the product code of K895880?
The FDA product code is CIL – Cresol Red Colorimetry, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.