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FDA 510(k)

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS

K-Number: K861016 · 1986-04-18

ApplicantGamma Biologicals, Inc.
Decision Date1986-04-18
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS 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 1986-04-18 under 510(k) number K861016. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS?

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS is a medical device that received FDA 510(k) clearance on 1986-04-18. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K861016.

When did GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS receive FDA 510(k) clearance?

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS received FDA 510(k) clearance on 1986-04-18, under 510(k) number K861016.

Who is the listed applicant for GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS?

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 GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS?

The FDA product code for GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS is KTN.

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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 MONOK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUSK811752FE-CULT PLUS

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Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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