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FDA 510(k)

SUPLEX & SUPLEX DILUENT

K-Number: K850302 · 1985-03-22

ApplicantPro-Lab, Inc.
Decision Date1985-03-22
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SUPLEX & SUPLEX DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1985-03-22 under 510(k) number K850302. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPLEX & SUPLEX DILUENT?

SUPLEX & SUPLEX DILUENT is a medical device that received FDA 510(k) clearance on 1985-03-22. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K850302.

When did SUPLEX & SUPLEX DILUENT receive FDA 510(k) clearance?

SUPLEX & SUPLEX DILUENT received FDA 510(k) clearance on 1985-03-22, under 510(k) number K850302.

Who is the listed applicant for SUPLEX & SUPLEX DILUENT?

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

What is the FDA product code for SUPLEX & SUPLEX DILUENT?

The FDA product code for SUPLEX & SUPLEX DILUENT is JSK.

Related Clinical Trials

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.

Other records listing Pro-Lab, 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.

View all 27 devices →

Related Devices (Code: JSK)

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.

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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