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FDA 510(k)

SED-FIX CONCENTRATE

K-Number: K852045 · 1985-06-10

ApplicantSurgipath Medical Industries, Inc.
Decision Date1985-06-10
Product CodeIER
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SED-FIX CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath Medical Industries, Inc.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K852045. The device is classified under product code IER. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SED-FIX CONCENTRATE?

SED-FIX CONCENTRATE is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Surgipath Medical Industries, Inc.. The 510(k) number is K852045.

When did SED-FIX CONCENTRATE receive FDA 510(k) clearance?

SED-FIX CONCENTRATE received FDA 510(k) clearance on 1985-06-10, under 510(k) number K852045.

Who is the listed applicant for SED-FIX CONCENTRATE?

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

What is the FDA product code for SED-FIX CONCENTRATE?

The FDA product code for SED-FIX CONCENTRATE is IER.

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Other records listing Surgipath Medical Industries, 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.

K883217SCHIFF REAGENTK881921C-E BRUSHK881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVEK881659TISSUE SECTION ADHESIVEK863549REUSABLE/DISPOSABLE AUTOPSY KNIFE SETK863616KNIFE MAKER

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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.

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