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FDA 510(k)

MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX

K-Number: K902541 · 1990-06-28

ApplicantTrinity Laboratories, Inc.
Decision Date1990-06-28
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1990-06-28 under 510(k) number K902541. 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 MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX?

MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K902541.

When did MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX receive FDA 510(k) clearance?

MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX received FDA 510(k) clearance on 1990-06-28, under 510(k) number K902541.

Who is the listed applicant for MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX?

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

What is the FDA product code for MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX?

The FDA product code for MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX is KTN.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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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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