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FDA 510(k)

FE-CULT PLUS

K-Number: K820072 · 1982-03-04

ApplicantGamma Biologicals, Inc.
Decision Date1982-03-04
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FE-CULT PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K820072. 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 FE-CULT PLUS?

FE-CULT PLUS is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K820072.

When did FE-CULT PLUS receive FDA 510(k) clearance?

FE-CULT PLUS received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820072.

Who is the listed applicant for FE-CULT PLUS?

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

What is the FDA product code for FE-CULT PLUS?

The FDA product code for FE-CULT PLUS is KHE.

Other records listing Gamma Biologicals, 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.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK811752FE-CULT PLUS

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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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