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FDA 510(k)

SM EIA DIAGNOSTIC KIT

K-Number: K870455 · 1987-03-17

ApplicantBiohytech International, Inc.
Decision Date1987-03-17
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SM EIA DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biohytech International, Inc.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K870455. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SM EIA DIAGNOSTIC KIT?

SM EIA DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Biohytech International, Inc.. The 510(k) number is K870455.

When did SM EIA DIAGNOSTIC KIT receive FDA 510(k) clearance?

SM EIA DIAGNOSTIC KIT received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870455.

Who is the listed applicant for SM EIA DIAGNOSTIC KIT?

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

What is the FDA product code for SM EIA DIAGNOSTIC KIT?

The FDA product code for SM EIA DIAGNOSTIC KIT is LJM.

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Other records listing Biohytech International, 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.

K870453DS-DNA EIA DIAGNOSTIC KITK870452SS-DNA EIA DIAGNOSTIC KITK870457RNP EIA DIAGNOSTIC KITK870458HISTONES EIA DIAGNOSTIC KITK870456DNP EIA DIAGNOSTIC KITK862969ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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