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FDA 510(k)

DYE CHECK STRIPS 545-630

K-Number: K943729 · 1994-12-29

ApplicantAwareness Technology, Inc.
Decision Date1994-12-29
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYE CHECK STRIPS 545-630 is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K943729. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYE CHECK STRIPS 545-630?

DYE CHECK STRIPS 545-630 is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K943729.

When did DYE CHECK STRIPS 545-630 receive FDA 510(k) clearance?

DYE CHECK STRIPS 545-630 received FDA 510(k) clearance on 1994-12-29, under 510(k) number K943729.

Who is the listed applicant for DYE CHECK STRIPS 545-630?

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

What is the FDA product code for DYE CHECK STRIPS 545-630?

The FDA product code for DYE CHECK STRIPS 545-630 is JJY.

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Other records listing Awareness Technology, Inc. as applicant

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Related Devices (Code: JJY)

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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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