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FDA 510(k)

EMIT II OPIATES 300/2000 ASSAY

K-Number: K971596 · 1997-06-25

ApplicantBehring Diagnostics, Inc.
Decision Date1997-06-25
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II OPIATES 300/2000 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K971596. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT II OPIATES 300/2000 ASSAY?

EMIT II OPIATES 300/2000 ASSAY is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K971596.

When did EMIT II OPIATES 300/2000 ASSAY receive FDA 510(k) clearance?

EMIT II OPIATES 300/2000 ASSAY received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971596.

Who is the listed applicant for EMIT II OPIATES 300/2000 ASSAY?

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

What is the FDA product code for EMIT II OPIATES 300/2000 ASSAY?

The FDA product code for EMIT II OPIATES 300/2000 ASSAY is DJG.

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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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