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FDA 510(k)

LYSIS +

K-Number: K830186 · 1983-02-28

ApplicantHematology Marketing Assoc.
Decision Date1983-02-28
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYSIS + is the device name listed in this FDA 510(k) record. The listed applicant is Hematology Marketing Assoc.. It received FDA 510(k) clearance on 1983-02-28 under 510(k) number K830186. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYSIS +?

LYSIS + is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Hematology Marketing Assoc.. The 510(k) number is K830186.

When did LYSIS + receive FDA 510(k) clearance?

LYSIS + received FDA 510(k) clearance on 1983-02-28, under 510(k) number K830186.

Who is the listed applicant for LYSIS +?

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

What is the FDA product code for LYSIS +?

The FDA product code for LYSIS + is GGK.

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Other records listing Hematology Marketing Assoc. 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.

K851843OSMOCEL 3K851375TRI-COUNTK850097LASER-LYSEK850096LASER-GLOBINK850095LASER-DILK850094LASER-GLOBIN POWDER

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Related Devices (Code: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, Inc.

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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