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FDA 510(k)

STANBIO ACETAMINOPHEN TEST SET #0850

K-Number: K801014 · 1980-06-20

ApplicantStanbio Laboratory
Decision Date1980-06-20
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STANBIO ACETAMINOPHEN TEST SET #0850 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801014. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANBIO ACETAMINOPHEN TEST SET #0850?

STANBIO ACETAMINOPHEN TEST SET #0850 is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Stanbio Laboratory. The 510(k) number is K801014.

When did STANBIO ACETAMINOPHEN TEST SET #0850 receive FDA 510(k) clearance?

STANBIO ACETAMINOPHEN TEST SET #0850 received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801014.

Who is the listed applicant for STANBIO ACETAMINOPHEN TEST SET #0850?

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 STANBIO ACETAMINOPHEN TEST SET #0850?

The FDA product code for STANBIO ACETAMINOPHEN TEST SET #0850 is LDP.

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Other records listing Stanbio Laboratory as applicant

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Related Devices (Code: LDP)

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.

K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.K110726ROCHE ACETAMINOPHEN ASSAYRoche DiagnosticsK100200ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare DiagnosticsK081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.

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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