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FDA 510(k)

ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY

K-Number: K881124 · 1988-04-18

ApplicantNichols Institute Diagnostics
Decision Date1988-04-18
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K881124. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY?

ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K881124.

When did ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY receive FDA 510(k) clearance?

ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY received FDA 510(k) clearance on 1988-04-18, under 510(k) number K881124.

Who is the listed applicant for ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY?

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

What is the FDA product code for ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY?

The FDA product code for ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY is CEP.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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Related Devices (Code: CEP)

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.

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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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