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FDA 510(k)

PROTOTRO/PROTEOLYTIC ENZYME CONTROL

K-Number: K831297 · 1983-06-08

ApplicantAmerican Dade
Decision Date1983-06-08
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTOTRO/PROTEOLYTIC ENZYME CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831297. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTOTRO/PROTEOLYTIC ENZYME CONTROL?

PROTOTRO/PROTEOLYTIC ENZYME CONTROL is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is American Dade. The 510(k) number is K831297.

When did PROTOTRO/PROTEOLYTIC ENZYME CONTROL receive FDA 510(k) clearance?

PROTOTRO/PROTEOLYTIC ENZYME CONTROL received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831297.

Who is the listed applicant for PROTOTRO/PROTEOLYTIC ENZYME CONTROL?

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

What is the FDA product code for PROTOTRO/PROTEOLYTIC ENZYME CONTROL?

The FDA product code for PROTOTRO/PROTEOLYTIC ENZYME CONTROL is JBQ.

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Other records listing American Dade as applicant

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Related Devices (Code: JBQ)

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

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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