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FDA 510(k)

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

K-Number: K864207 · 1986-12-03

ApplicantGamma Biologicals, Inc.
Decision Date1986-12-03
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO 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 1986-12-03 under 510(k) number K864207. 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 DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO?

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO is a medical device that received FDA 510(k) clearance on 1986-12-03. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K864207.

When did DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO receive FDA 510(k) clearance?

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO received FDA 510(k) clearance on 1986-12-03, under 510(k) number K864207.

Who is the listed applicant for DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO?

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 DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO?

The FDA product code for DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO 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.

K861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUSK811752FE-CULT PLUS

View all 21 devices →

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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