FDA 510(k)

EA 65

K-Number: K812086 · 1981-08-13

Decision Date1981-08-13

Product CodeHZJ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

EA 65 is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K812086. 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 EA 65?

EA 65 is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Surgipath. The 510(k) number is K812086.

When did EA 65 receive FDA 510(k) clearance?

EA 65 received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812086.

Who is the listed applicant for EA 65?

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 EA 65?

The FDA product code for EA 65 is HZJ.

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.

K820027MODIFIED EA 50 K81294010% NEUTRAL BUFFERED FORMALIN CONCENT K812087EA 50 K811825ORANGE G-6 K811826EOSIN Y K810836DECALCIFIER II

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Related Devices (Code: HZJ)

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