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FDA 510(k)

CHEM-ASSAY STANDARD-CONTROLS

K-Number: K802962 · 1980-12-22

ApplicantNational Bio-Technical Laboratories
Decision Date1980-12-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-ASSAY STANDARD-CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is National Bio-Technical Laboratories. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802962. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM-ASSAY STANDARD-CONTROLS?

CHEM-ASSAY STANDARD-CONTROLS is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is National Bio-Technical Laboratories. The 510(k) number is K802962.

When did CHEM-ASSAY STANDARD-CONTROLS receive FDA 510(k) clearance?

CHEM-ASSAY STANDARD-CONTROLS received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802962.

Who is the listed applicant for CHEM-ASSAY STANDARD-CONTROLS?

The FDA 510(k) record lists National Bio-Technical Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEM-ASSAY STANDARD-CONTROLS?

The FDA product code for CHEM-ASSAY STANDARD-CONTROLS is JJY.

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Related Devices (Code: JJY)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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