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FDA 510(k)

RNA1C CONTROL FOR NYCOCARD HBA1C

K-Number: K050961 · 2005-05-13

ApplicantBionostics, Inc.
Decision Date2005-05-13
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RNA1C CONTROL FOR NYCOCARD HBA1C is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2005-05-13 under 510(k) number K050961. 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 RNA1C CONTROL FOR NYCOCARD HBA1C?

RNA1C CONTROL FOR NYCOCARD HBA1C is a medical device that received FDA 510(k) clearance on 2005-05-13. The listed applicant is Bionostics, Inc.. The 510(k) number is K050961.

When did RNA1C CONTROL FOR NYCOCARD HBA1C receive FDA 510(k) clearance?

RNA1C CONTROL FOR NYCOCARD HBA1C received FDA 510(k) clearance on 2005-05-13, under 510(k) number K050961.

Who is the listed applicant for RNA1C CONTROL FOR NYCOCARD HBA1C?

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

What is the FDA product code for RNA1C CONTROL FOR NYCOCARD HBA1C?

The FDA product code for RNA1C CONTROL FOR NYCOCARD HBA1C 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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