FDA 510(k)

ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B

K-Number: K974181 · 1997-12-11

Decision Date1997-12-11

Product CodeJXM

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K974181. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B?

ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K974181.

When did ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B receive FDA 510(k) clearance?

ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B received FDA 510(k) clearance on 1997-12-11, under 510(k) number K974181.

Who is the listed applicant for ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B?

The FDA product code for ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B is JXM.

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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.