FDA 510(k)

PAPANICOLAOU STAIN SYS HT40

K-Number: K840054 · 1984-02-17

Decision Date1984-02-17

Product CodeHZJ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PAPANICOLAOU STAIN SYS HT40 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 1984-02-17 under 510(k) number K840054. 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 PAPANICOLAOU STAIN SYS HT40?

PAPANICOLAOU STAIN SYS HT40 is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Sigma Chemical Co.. The 510(k) number is K840054.

When did PAPANICOLAOU STAIN SYS HT40 receive FDA 510(k) clearance?

PAPANICOLAOU STAIN SYS HT40 received FDA 510(k) clearance on 1984-02-17, under 510(k) number K840054.

Who is the listed applicant for PAPANICOLAOU STAIN SYS HT40?

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 PAPANICOLAOU STAIN SYS HT40?

The FDA product code for PAPANICOLAOU STAIN SYS HT40 is HZJ.

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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: HZJ)

K843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6Accra Laboratories, Inc.K842739PAP STAIN, EA-36E K Ind., Inc.K842735PAP STAIN EA-65E K Ind., Inc.K842738PAP STAIN EA-50E K Ind., Inc.K842736PAP STAIN, OG-6E K Ind., Inc.K822035VOLU-SOL GILLS EAVolu Sol Medical Industries

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.