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FDA 510(k)

HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED

K-Number: K881477 · 1988-04-18

ApplicantStat Path
Decision Date1988-04-18
Product CodeKEL
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED is the device name listed in this FDA 510(k) record. The listed applicant is Stat Path. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K881477. The device is classified under product code KEL. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED?

HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Stat Path. The 510(k) number is K881477.

When did HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED receive FDA 510(k) clearance?

HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED received FDA 510(k) clearance on 1988-04-18, under 510(k) number K881477.

Who is the listed applicant for HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED?

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

What is the FDA product code for HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED?

The FDA product code for HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED is KEL.

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Other records listing Stat Path 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.

K890042MICROSCOPE SLIDES PRECOATEDK882362STAT FIX MICROWAVE IRRADIATION MEDIUMK882357MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY

Related Devices (Code: KEL)

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.

K890022ATS MAYER'S ALBUMINAlpha-Tec Systems, Inc.

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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