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FDA 510(k)

MONO-TEC

K-Number: K841863 · 1984-06-13

ApplicantMedilab Corp.
Decision Date1984-06-13
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO-TEC is the device name listed in this FDA 510(k) record. The listed applicant is Medilab Corp.. It received FDA 510(k) clearance on 1984-06-13 under 510(k) number K841863. 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-TEC?

MONO-TEC is a medical device that received FDA 510(k) clearance on 1984-06-13. The listed applicant is Medilab Corp.. The 510(k) number is K841863.

When did MONO-TEC receive FDA 510(k) clearance?

MONO-TEC received FDA 510(k) clearance on 1984-06-13, under 510(k) number K841863.

Who is the listed applicant for MONO-TEC?

The FDA 510(k) record lists Medilab Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONO-TEC?

The FDA product code for MONO-TEC is KTN.

Other records listing Medilab Corp. 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.

K841862IMMU-TECK840290MCS TOTAL PROTEIN REAGENTK840291MCS ALBUMIN REAGENTK840289LYSE-TECK832918PREGNA-TECK832527PREGNA-TEC

View all 7 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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