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FDA 510(k)

ISOTONIC DILUENT AF

K-Number: K761182 · 1976-12-09

ApplicantCentral Labs. Assoc. MD Pathologists
Decision Date1976-12-09
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ISOTONIC DILUENT AF is the device name listed in this FDA 510(k) record. The listed applicant is Central Labs. Assoc. MD Pathologists. It received FDA 510(k) clearance on 1976-12-09 under 510(k) number K761182. 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 ISOTONIC DILUENT AF?

ISOTONIC DILUENT AF is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Central Labs. Assoc. MD Pathologists. The 510(k) number is K761182.

When did ISOTONIC DILUENT AF receive FDA 510(k) clearance?

ISOTONIC DILUENT AF received FDA 510(k) clearance on 1976-12-09, under 510(k) number K761182.

Who is the listed applicant for ISOTONIC DILUENT AF?

The FDA 510(k) record lists Central Labs. Assoc. MD Pathologists as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOTONIC DILUENT AF?

The FDA product code for ISOTONIC DILUENT AF is GGK.

Related Clinical Trials

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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Other records listing Central Labs. Assoc. MD Pathologists 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.

K771201FORMALIN BUFFER CONCENTRATEK761183LYSING AGENT AF

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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