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FDA 510(k)

MODIFIED EA 50

K-Number: K820027 · 1982-02-04

ApplicantSurgipath
Decision Date1982-02-04
Product CodeHZJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFIED EA 50 is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820027. The device is classified under product code HZJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED EA 50?

MODIFIED EA 50 is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Surgipath. The 510(k) number is K820027.

When did MODIFIED EA 50 receive FDA 510(k) clearance?

MODIFIED EA 50 received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820027.

Who is the listed applicant for MODIFIED EA 50?

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

What is the FDA product code for MODIFIED EA 50?

The FDA product code for MODIFIED EA 50 is HZJ.

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Other records listing Surgipath 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.

K81294010% NEUTRAL BUFFERED FORMALIN CONCENTK812087EA 50K812086EA 65K811826EOSIN YK811825ORANGE G-6K810836DECALCIFIER II

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Related Devices (Code: HZJ)

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.

K843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6Accra Laboratories, Inc.K842735PAP STAIN EA-65E K Ind., Inc.K842739PAP STAIN, EA-36E K Ind., Inc.K842738PAP STAIN EA-50E K Ind., Inc.K842736PAP STAIN, OG-6E K Ind., Inc.K840054PAPANICOLAOU STAIN SYS HT40Sigma Chemical Co.

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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