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FDA 510(k)

TOTAL HEMOLYTIC COMPLEMENT TEST KIT

K-Number: K820005 · 1982-01-22

ApplicantMeloy Laboratories, Inc.
Decision Date1982-01-22
Product Code
DecisionSubstantially Equivalent

Device Summary

TOTAL HEMOLYTIC COMPLEMENT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Meloy Laboratories, Inc.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K820005. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL HEMOLYTIC COMPLEMENT TEST KIT?

TOTAL HEMOLYTIC COMPLEMENT TEST KIT is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K820005.

When did TOTAL HEMOLYTIC COMPLEMENT TEST KIT receive FDA 510(k) clearance?

TOTAL HEMOLYTIC COMPLEMENT TEST KIT received FDA 510(k) clearance on 1982-01-22, under 510(k) number K820005.

Who is the listed applicant for TOTAL HEMOLYTIC COMPLEMENT TEST KIT?

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

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Other records listing Meloy Laboratories, 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.

K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAYK844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CULK841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIIIK842247MELOY AUTOANTIBODY TEST SYSK831292ANTI-ENA TESTK820265ANA TEST (MOUSE LIVER SUBSTRATE)

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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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