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FDA 510(k)

ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.

K-Number: K881123 · 1988-04-28

ApplicantNichols Institute Diagnostics
Decision Date1988-04-28
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. 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 1988-04-28 under 510(k) number K881123. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.?

ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K881123.

When did ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. receive FDA 510(k) clearance?

ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881123.

Who is the listed applicant for ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.?

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) FOLLICLE STIMULATING HORMONE IMMUNO.?

The FDA product code for ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. is CGJ.

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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: CGJ)

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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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