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FDA 510(k)

POLYSTAT, BIOLOGICAL STAIN

K-Number: K844640 · 1985-01-30

ApplicantSurgipath Medical Industries, Inc.
Decision Date1985-01-30
Product CodeIAB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POLYSTAT, BIOLOGICAL STAIN 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 1985-01-30 under 510(k) number K844640. The device is classified under product code IAB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSTAT, BIOLOGICAL STAIN?

POLYSTAT, BIOLOGICAL STAIN is a medical device that received FDA 510(k) clearance on 1985-01-30. The listed applicant is Surgipath Medical Industries, Inc.. The 510(k) number is K844640.

When did POLYSTAT, BIOLOGICAL STAIN receive FDA 510(k) clearance?

POLYSTAT, BIOLOGICAL STAIN received FDA 510(k) clearance on 1985-01-30, under 510(k) number K844640.

Who is the listed applicant for POLYSTAT, BIOLOGICAL STAIN?

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 POLYSTAT, BIOLOGICAL STAIN?

The FDA product code for POLYSTAT, BIOLOGICAL STAIN is IAB.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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