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FDA 510(k)

BIOSITE DIAGNOSTICS OPIATE SCREENING TEST

K-Number: K902924 · 1990-09-14

ApplicantBiosite Incorporated
Decision Date1990-09-14
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOSITE DIAGNOSTICS OPIATE SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 1990-09-14 under 510(k) number K902924. 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 BIOSITE DIAGNOSTICS OPIATE SCREENING TEST?

BIOSITE DIAGNOSTICS OPIATE SCREENING TEST is a medical device that received FDA 510(k) clearance on 1990-09-14. The listed applicant is Biosite Incorporated. The 510(k) number is K902924.

When did BIOSITE DIAGNOSTICS OPIATE SCREENING TEST receive FDA 510(k) clearance?

BIOSITE DIAGNOSTICS OPIATE SCREENING TEST received FDA 510(k) clearance on 1990-09-14, under 510(k) number K902924.

Who is the listed applicant for BIOSITE DIAGNOSTICS OPIATE SCREENING TEST?

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

What is the FDA product code for BIOSITE DIAGNOSTICS OPIATE SCREENING TEST?

The FDA product code for BIOSITE DIAGNOSTICS OPIATE SCREENING TEST is DJG.

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Other records listing Biosite Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092987INRATIO/INRATIO2 TEST STRIPSK092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPK093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETK080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSK072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

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Related Devices (Code: 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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