FDA 510(k)

HEMOLYSIN

K-Number: K812371 · 1981-09-08

Decision Date1981-09-08

Product Code

DecisionSubstantially Equivalent

Device Summary

HEMOLYSIN is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812371. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOLYSIN?

HEMOLYSIN is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K812371.

When did HEMOLYSIN receive FDA 510(k) clearance?

HEMOLYSIN received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812371.

Who is the listed applicant for HEMOLYSIN?

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

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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.