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FDA 510(k)

TRI-CHECK

K-Number: K800938 · 1980-05-08

ApplicantScientific Standards, Inc.
Decision Date1980-05-08
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRI-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Standards, Inc.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800938. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-CHECK?

TRI-CHECK is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Scientific Standards, Inc.. The 510(k) number is K800938.

When did TRI-CHECK receive FDA 510(k) clearance?

TRI-CHECK received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800938.

Who is the listed applicant for TRI-CHECK?

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

What is the FDA product code for TRI-CHECK?

The FDA product code for TRI-CHECK is JPK.

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Other records listing Scientific Standards, Inc. 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.

K810756HEMOTOLOGY QUALITY CONTROL MIXTURES

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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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