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FDA 510(k)

PAPANICOLAOU STAIN EA-36

K-Number: K781582 · 1978-10-10

ApplicantBioscientific
Decision Date1978-10-10
Product CodeHZJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PAPANICOLAOU STAIN EA-36 is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781582. 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 EA-36?

PAPANICOLAOU STAIN EA-36 is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Bioscientific. The 510(k) number is K781582.

When did PAPANICOLAOU STAIN EA-36 receive FDA 510(k) clearance?

PAPANICOLAOU STAIN EA-36 received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781582.

Who is the listed applicant for PAPANICOLAOU STAIN EA-36?

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

What is the FDA product code for PAPANICOLAOU STAIN EA-36?

The FDA product code for PAPANICOLAOU STAIN EA-36 is HZJ.

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Other records listing Bioscientific 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.

K812447AMYLASE REAGENT KITK811251CITRATE BUFFERK801268HEMOGLOBIN CONTROL LEVELSK801265WHITE BLOOD CELL COUNT CONTROL LEVELSK801267RED BLOOD CELL COUNT & HEMATOCRIT CNTLK791658WRIGHT STAIN PACK

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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.

K843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6Accra Laboratories, Inc.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.

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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