PRONTO DRY— 510(k) K991248

Name: FDA 510(k) clearance K991248
Creator: U.S. Food and Drug Administration
Published: 1999-06-22

Substantially Equivalent

Medical Instruments Corporation Mic AG

FDA 510(k) clearance K991248 for PRONTO DRY, Substantially Equivalent on 1999-06-22. Applicant: Medical Instruments Corporation Mic AG. Device class: 1.

Clearance details

Applicant: Medical Instruments Corporation Mic AG
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1999-04-12
Decision date: 1999-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solothurn, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYR

view all

K232892 — Hp Detect Stool Antigen ELISA2023-12-15
K230901 — Premier HpSA Flex (619096)2023-07-03
K192817 — Curian HpSA, Curian Analyzer2020-03-13
K183573 — Vstrip H. pylori Antigen Rapid Test2019-03-14
K182559 — PREMIER Platinum HpSA PLUS2018-11-05

More clearances from Medical Instruments Corporation Mic AG

view all

K950087 — LOT 4401996-02-06

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.