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FDA 510(k)

A1C-CELLULAR

K-Number: K040025 · 2004-03-02

ApplicantStreck Laboratories, Inc.
Decision Date2004-03-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A1C-CELLULAR is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K040025. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A1C-CELLULAR?

A1C-CELLULAR is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K040025.

When did A1C-CELLULAR receive FDA 510(k) clearance?

A1C-CELLULAR received FDA 510(k) clearance on 2004-03-02, under 510(k) number K040025.

Who is the listed applicant for A1C-CELLULAR?

The FDA 510(k) record lists Streck Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A1C-CELLULAR?

The FDA product code for A1C-CELLULAR is JJX.

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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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