FDA 510(k)

FORMALIN SOLUTION 10% NEUTRAL BUFFER

K-Number: K840926 · 1984-03-12

Decision Date1984-03-12

Product CodeIFP

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

FORMALIN SOLUTION 10% NEUTRAL BUFFER 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 1984-03-12 under 510(k) number K840926. The device is classified under product code IFP. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORMALIN SOLUTION 10% NEUTRAL BUFFER?

FORMALIN SOLUTION 10% NEUTRAL BUFFER is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Sigma Chemical Co.. The 510(k) number is K840926.

When did FORMALIN SOLUTION 10% NEUTRAL BUFFER receive FDA 510(k) clearance?

FORMALIN SOLUTION 10% NEUTRAL BUFFER received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840926.

Who is the listed applicant for FORMALIN SOLUTION 10% NEUTRAL BUFFER?

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 FORMALIN SOLUTION 10% NEUTRAL BUFFER?

The FDA product code for FORMALIN SOLUTION 10% NEUTRAL BUFFER is IFP.

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Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: IFP)

K884755CONSED FECAL CONCENTRATION SYSTEMDonald L. Price, Ph.D.K872663DRY-FORMAnatech, Ltd.K872140(MSI) PATH-SAVERMedical Specialties, Inc.K870852NBF 10% NEUTRAL BUFFERED FORMALINAnatech, Ltd.K853497PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALINSurgipath Medical Industries, Inc.K842982FORMALIN BUFFEREDReagent 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.