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FDA 510(k)

HEMA-SCREEN

K-Number: K902360 · 1990-07-27

ApplicantImmunostics Co., Inc.
Decision Date1990-07-27
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMA-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1990-07-27 under 510(k) number K902360. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMA-SCREEN?

HEMA-SCREEN is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K902360.

When did HEMA-SCREEN receive FDA 510(k) clearance?

HEMA-SCREEN received FDA 510(k) clearance on 1990-07-27, under 510(k) number K902360.

Who is the listed applicant for HEMA-SCREEN?

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

What is the FDA product code for HEMA-SCREEN?

The FDA product code for HEMA-SCREEN is KHE.

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Other records listing Immunostics Co., 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.

K926569IMMUNO RA UNDILUTEDK894780IMMUNO/ASOK883685IMMUNO/FEBRILE ANTIGENSK872910IMMUNO/SLEK863741IMMUNO-CEPT D (BETA-MONOCLONAL)K854619DETECTACULT

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Related Devices (Code: KHE)

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.

K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC

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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