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FDA 510(k)

I.M.N. LATEX

K-Number: K874678 · 1987-12-14

ApplicantBiokit USA, Inc.
Decision Date1987-12-14
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

I.M.N. LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1987-12-14 under 510(k) number K874678. 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 I.M.N. LATEX?

I.M.N. LATEX is a medical device that received FDA 510(k) clearance on 1987-12-14. The listed applicant is Biokit USA, Inc.. The 510(k) number is K874678.

When did I.M.N. LATEX receive FDA 510(k) clearance?

I.M.N. LATEX received FDA 510(k) clearance on 1987-12-14, under 510(k) number K874678.

Who is the listed applicant for I.M.N. LATEX?

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

What is the FDA product code for I.M.N. LATEX?

The FDA product code for I.M.N. LATEX is KTN.

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Other records listing Biokit USA, 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.

K913467TOXOGENK910541BIOKIT RPRK904310RHEUMAGEN RF T-CONTROLK910539RHEUMAJET RFK910686RHEUMAJET CRPK904311RHEUMAGEN ASO T-CONTROL

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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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