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FDA 510(k)

BARBITURATE TEST SET #0550-050

K-Number: K823237 · 1982-11-29

ApplicantStanbio Laboratory
Decision Date1982-11-29
Product CodeDJN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BARBITURATE TEST SET #0550-050 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823237. The device is classified under product code DJN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARBITURATE TEST SET #0550-050?

BARBITURATE TEST SET #0550-050 is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Stanbio Laboratory. The 510(k) number is K823237.

When did BARBITURATE TEST SET #0550-050 receive FDA 510(k) clearance?

BARBITURATE TEST SET #0550-050 received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823237.

Who is the listed applicant for BARBITURATE TEST SET #0550-050?

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

What is the FDA product code for BARBITURATE TEST SET #0550-050?

The FDA product code for BARBITURATE TEST SET #0550-050 is DJN.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050283CREATININE LIQUICOLORK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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