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FDA 510(k)

COMBI-SCREEN, MODELS 10SL AND 11SL

K-Number: K023885 · 2003-10-21

ApplicantAnalyticon Biotechnologies AG
Decision Date2003-10-21
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMBI-SCREEN, MODELS 10SL AND 11SL is the device name listed in this FDA 510(k) record. The listed applicant is Analyticon Biotechnologies AG. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K023885. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBI-SCREEN, MODELS 10SL AND 11SL?

COMBI-SCREEN, MODELS 10SL AND 11SL is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Analyticon Biotechnologies AG. The 510(k) number is K023885.

When did COMBI-SCREEN, MODELS 10SL AND 11SL receive FDA 510(k) clearance?

COMBI-SCREEN, MODELS 10SL AND 11SL received FDA 510(k) clearance on 2003-10-21, under 510(k) number K023885.

Who is the listed applicant for COMBI-SCREEN, MODELS 10SL AND 11SL?

The FDA 510(k) record lists Analyticon Biotechnologies AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBI-SCREEN, MODELS 10SL AND 11SL?

The FDA product code for COMBI-SCREEN, MODELS 10SL AND 11SL is JIL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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