FDA 510(k)

HISTOPAQUE-1077

K-Number: K842146 · 1984-07-27

Decision Date1984-07-27

Product CodeJCF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HISTOPAQUE-1077 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1984-07-27 under 510(k) number K842146. The device is classified under product code JCF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOPAQUE-1077?

HISTOPAQUE-1077 is a medical device that received FDA 510(k) clearance on 1984-07-27. The listed applicant is Sigma Chemical Co.. The 510(k) number is K842146.

When did HISTOPAQUE-1077 receive FDA 510(k) clearance?

HISTOPAQUE-1077 received FDA 510(k) clearance on 1984-07-27, under 510(k) number K842146.

Who is the listed applicant for HISTOPAQUE-1077?

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

What is the FDA product code for HISTOPAQUE-1077?

The FDA product code for HISTOPAQUE-1077 is JCF.

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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.