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FDA 510(k)

HEMOLYSE

K-Number: K863503 · 1986-10-03

ApplicantReagent Laboratory, Inc.
Decision Date1986-10-03
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOLYSE is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1986-10-03 under 510(k) number K863503. 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 HEMOLYSE?

HEMOLYSE is a medical device that received FDA 510(k) clearance on 1986-10-03. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K863503.

When did HEMOLYSE receive FDA 510(k) clearance?

HEMOLYSE received FDA 510(k) clearance on 1986-10-03, under 510(k) number K863503.

Who is the listed applicant for HEMOLYSE?

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

What is the FDA product code for HEMOLYSE?

The FDA product code for HEMOLYSE is GGK.

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Other records listing Reagent Laboratory, 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863550POTASSIUM HYDROXIDE 10% W/VK860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEK842982FORMALIN BUFFEREDK842785STAIN, METHYLENE BLUE-EOSINK843050GRAM STAIN

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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.K850097LASER-LYSEHematology Marketing Assoc.

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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