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FDA 510(k)

COLOR-MONOGEN

K-Number: K012901 · 2001-09-27

ApplicantInstrumentation Laboratory CO
Decision Date2001-09-27
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COLOR-MONOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2001-09-27 under 510(k) number K012901. 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 COLOR-MONOGEN?

COLOR-MONOGEN is a medical device that received FDA 510(k) clearance on 2001-09-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K012901.

When did COLOR-MONOGEN receive FDA 510(k) clearance?

COLOR-MONOGEN received FDA 510(k) clearance on 2001-09-27, under 510(k) number K012901.

Who is the listed applicant for COLOR-MONOGEN?

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

What is the FDA product code for COLOR-MONOGEN?

The FDA product code for COLOR-MONOGEN is KTN.

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Other records listing Instrumentation Laboratory CO as applicant

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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 COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.K972457MONOCOL/LEX-IM TESTImmunostics Inc.,

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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