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FDA 510(k)

LECTIN-A

K-Number: K820368 · 1982-04-14

ApplicantAmerican Dade
Decision Date1982-04-14
Product CodeKSI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LECTIN-A is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820368. The device is classified under product code KSI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LECTIN-A?

LECTIN-A is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is American Dade. The 510(k) number is K820368.

When did LECTIN-A receive FDA 510(k) clearance?

LECTIN-A received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820368.

Who is the listed applicant for LECTIN-A?

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

What is the FDA product code for LECTIN-A?

The FDA product code for LECTIN-A is KSI.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: KSI)

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.

K813413LECTIN HAmerican DadeK792582POLY-LEC SYSTEMGamma Biologicals, Inc.K792583GAMMA ARACHIS HYPOGEA LECTINGamma Biologicals, 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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