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FDA 510(k)

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6

K-Number: K843427 · 1984-10-02

ApplicantAccra Laboratories, Inc.
Decision Date1984-10-02
Product CodeHZJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1984-10-02 under 510(k) number K843427. 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 GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6?

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K843427.

When did GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 receive FDA 510(k) clearance?

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 received FDA 510(k) clearance on 1984-10-02, under 510(k) number K843427.

Who is the listed applicant for GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6?

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

What is the FDA product code for GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6?

The FDA product code for GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 is HZJ.

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Other records listing Accra Laboratories, 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.

K851494TWO-STEP ACID FAST BACTERIA STAINK851493KINYOUN ACID FAST STAIN KITK843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843426EOSIN Y 1% ALCOHOLICK843428BIOFIXK843429GRAM STAIN SET W/STABILIZED IODINE

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Related Devices (Code: HZJ)

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.

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.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.

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